{"id":33091,"date":"2026-09-24T02:53:57","date_gmt":"2026-09-24T06:53:57","guid":{"rendered":"https:\/\/www.rigicon.com\/us-regulatory-status-7\/"},"modified":"2026-09-24T03:33:05","modified_gmt":"2026-09-24T07:33:05","slug":"us-regulatory-status","status":"publish","type":"page","link":"https:\/\/www.rigicon.com\/hi\/us-regulatory-status\/","title":{"rendered":"\u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0928\u093f\u092f\u093e\u092e\u0915 \u0938\u094d\u0925\u093f\u0924\u093f"},"content":{"rendered":"<style>\n.rigicon-doc{box-sizing:border-box;max-width:46rem;margin-inline:auto;background:#fff;\n border-radius:16px;padding:48px 56px;\n box-shadow:0 1px 3px rgba(35,47,88,.06),0 14px 40px rgba(35,47,88,.10);\n color:#505050;font-size:17px;line-height:1.75;}\n.rigicon-doc p{margin:0 0 20px;}\n.rigicon-doc .uk-text-lead{font-size:19px;line-height:1.7;color:#3c4350;\n margin-bottom:28px;}\n.rigicon-doc h2{color:#232F58;font-size:22px;line-height:1.35;font-weight:600;\n margin:40px 0 14px;}\n.rigicon-doc a{color:#194F90;text-decoration:underline;text-underline-offset:2px;}\n.rigicon-doc a:hover{color:#232F58;}\n.rigicon-doc .uk-text-meta{font-size:14px;color:#7a7a7a;}\n.rigicon-doc sup{font-size:.62em;}\n\/* sayfa basligi ortada *\/\n.uk-article-title{text-align:center;}\n\/* kartin one ciktigi acik zemin *\/\n.tm-main{background:#f5f6f8;}\n@media (max-width:640px){\n .rigicon-doc{padding:28px 22px;border-radius:12px;font-size:16px;}\n .rigicon-doc .uk-text-lead{font-size:17px;}\n .rigicon-doc h2{font-size:20px;margin-top:32px;}\n}\n<\/style>\n<div class=\"rigicon-doc\">\n<p class=\"uk-text-lead\">Rigicon \u0915\u0947 \u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u0908 \u0926\u0947\u0936\u094b\u0902 \u092e\u0947\u0902 \u0935\u093f\u0924\u0930\u093f\u0924 \u0915\u093f\u090f \u091c\u093e\u0924\u0947 \u0939\u0948\u0902\u0964 \u0928\u093f\u092f\u093e\u092e\u0915 \u0938\u094d\u0925\u093f\u0924\u093f \u0914\u0930 \u0909\u092a\u0932\u092c\u094d\u0927\u0924\u093e \u0926\u0947\u0936 \u0915\u0947 \u0905\u0928\u0941\u0938\u093e\u0930 \u092d\u093f\u0928\u094d\u0928 \u0939\u094b\u0924\u0940 \u0939\u0948\u0964 \u092f\u0939 \u092a\u0943\u0937\u094d\u0920 \u0915\u0947\u0935\u0932 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u0915\u0940 \u0938\u094d\u0925\u093f\u0924\u093f \u0915\u093e \u0935\u0930\u094d\u0923\u0928 \u0915\u0930\u0924\u093e \u0939\u0948\u0964<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">\u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u092c\u093f\u0915\u094d\u0930\u0940 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u0932\u092c\u094d\u0927 \u0928\u0939\u0940\u0902 \u0909\u0924\u094d\u092a\u093e\u0926<\/h2>\n<p>Infla10<sup>&reg;<\/sup>, Infla2P<sup>&trade;<\/sup>, ContiReflex<sup>&reg;<\/sup>, ContiClassic<sup>&reg;<\/sup> \u0914\u0930 Testi10<sup>&trade;<\/sup> \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u092c\u093f\u0915\u094d\u0930\u0940 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u0932\u092c\u094d\u0927 \u0928\u0939\u0940\u0902 \u0939\u0948\u0902\u0964<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Rigi10<sup>&trade;<\/sup> \u092e\u0948\u0932\u093f\u090f\u092c\u0932 \u092a\u0947\u0928\u093e\u0907\u0932 \u092a\u094d\u0930\u094b\u0938\u094d\u0925\u0947\u0938\u093f\u0938<\/h2>\n<p>Rigi10<sup>&trade;<\/sup> \u092e\u0948\u0932\u093f\u090f\u092c\u0932 \u092a\u0947\u0928\u093e\u0907\u0932 \u092a\u094d\u0930\u094b\u0938\u094d\u0925\u0947\u0938\u093f\u0938 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 9, 10, 11, 12 \u0914\u0930 13&nbsp;mm \u0935\u094d\u092f\u093e\u0938 \u092e\u0947\u0902 \u0909\u092a\u0932\u092c\u094d\u0927 \u0939\u0948\u0964 14&nbsp;mm \u0915\u093e \u0906\u0915\u093e\u0930 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u092c\u093f\u0915\u094d\u0930\u0940 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u0932\u092c\u094d\u0927 \u0928\u0939\u0940\u0902 \u0939\u0948\u0964<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Infla10<sup>&reg;<\/sup> \u2014 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0905\u0928\u0941\u0938\u0902\u0927\u093e\u0928\u093e\u0927\u0940\u0928<\/h2>\n<div class=\"uk-alert uk-margin-small-top\" role=\"note\" style=\"background:#fff8e6;border-inline-start:4px solid #e08e0b;border-radius:8px;padding:18px 22px;margin:0 0 20px;\">\n<p class=\"uk-margin-remove\"><strong>CAUTION\u2014Investigational device. Limited by Federal (or United States) law to investigational use.<\/strong><\/p>\n<\/div>\n<p class=\"uk-text-meta uk-margin-small-top\">(\u0935\u093f\u0927\u093f\u0915 \u0930\u0942\u092a \u0938\u0947 \u0905\u0928\u093f\u0935\u093e\u0930\u094d\u092f \u0938\u0942\u091a\u0928\u093e \u0915\u093e \u0905\u0928\u0941\u0935\u093e\u0926: \u201c\u0938\u093e\u0935\u0927\u093e\u0928\u0940 \u2014 \u0905\u0928\u0941\u0938\u0902\u0927\u093e\u0928\u093e\u0927\u0940\u0928 \u0909\u092a\u0915\u0930\u0923\u0964 \u0938\u0902\u0918\u0940\u092f (\u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f) \u0915\u093e\u0928\u0942\u0928 \u0926\u094d\u0935\u093e\u0930\u093e \u0915\u0947\u0935\u0932 \u0905\u0928\u0941\u0938\u0902\u0927\u093e\u0928 \u0909\u092a\u092f\u094b\u0917 \u0924\u0915 \u0938\u0940\u092e\u093f\u0924\u0964\u201d \u0905\u0902\u0917\u094d\u0930\u0947\u091c\u093c\u0940 \u092a\u093e\u0920 \u0939\u0940 \u092e\u093e\u0928\u094d\u092f \u0939\u0948\u0964)<\/p>\n<p>\u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 Infla10<sup>&reg;<\/sup> Pulse<sup>&trade;<\/sup> Dynamic Inflatable Penile Prosthesis \u090f\u0915 \u0905\u0928\u0941\u0938\u0902\u0927\u093e\u0928\u093e\u0927\u0940\u0928 \u0909\u092a\u0915\u0930\u0923 \u0939\u0948\u0964 \u0907\u0938\u0915\u093e \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 UNITED \u0905\u0927\u094d\u092f\u092f\u0928 \u092e\u0947\u0902 \u0915\u093f\u092f\u093e \u091c\u093e \u0930\u0939\u093e \u0939\u0948, \u091c\u094b FDA \u0926\u094d\u0935\u093e\u0930\u093e \u0905\u0928\u0941\u092e\u094b\u0926\u093f\u0924 Investigational Device Exemption (IDE) \u0915\u0947 \u0905\u0902\u0924\u0930\u094d\u0917\u0924 \u0938\u0902\u091a\u093e\u0932\u093f\u0924 \u090f\u0915 \u0938\u0902\u092d\u093e\u0935\u094d\u092f, \u092c\u0939\u0941\u0915\u0947\u0902\u0926\u094d\u0930\u0940\u092f, \u090f\u0915\u0932-\u092d\u0941\u091c\u093e \u0905\u0927\u094d\u092f\u092f\u0928 \u0939\u0948\u0964 ClinicalTrials.gov \u092a\u0939\u091a\u093e\u0928\u0915\u0930\u094d\u0924\u093e: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT07273773\" rel=\"noopener\">NCT07273773<\/a>\u0964<\/p>\n<p>\u092f\u0939 \u0909\u092a\u0915\u0930\u0923 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0935\u093e\u0923\u093f\u091c\u094d\u092f\u093f\u0915 \u0935\u093f\u0924\u0930\u0923 \u0939\u0947\u0924\u0941 FDA \u0926\u094d\u0935\u093e\u0930\u093e \u0905\u0928\u0941\u092e\u094b\u0926\u093f\u0924 \u0928\u0939\u0940\u0902 \u0939\u0948\u0964 \u0905\u0927\u094d\u092f\u092f\u0928 \u092a\u0942\u0930\u094d\u0923 \u0939\u094b\u0928\u0947 \u0914\u0930 FDA \u0926\u094d\u0935\u093e\u0930\u093e \u092a\u0930\u093f\u0923\u093e\u092e\u094b\u0902 \u0915\u0940 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0915\u093f\u090f \u091c\u093e\u0928\u0947 \u0924\u0915, \u0905\u0928\u0941\u0938\u0902\u0927\u093e\u0928\u093e\u0927\u0940\u0928 \u0909\u092a\u092f\u094b\u0917 \u0915\u0947 \u0932\u093f\u090f \u0907\u0938\u0915\u0940 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u092f\u093e \u092a\u094d\u0930\u092d\u093e\u0935\u0915\u093e\u0930\u093f\u0924\u093e \u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902 \u0915\u094b\u0908 \u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937 \u0928\u0939\u0940\u0902 \u0928\u093f\u0915\u093e\u0932\u093e \u091c\u093e \u0938\u0915\u0924\u093e\u0964<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">\u092a\u0930\u094d\u091a\u0947 \u0915\u0940 \u0906\u0935\u0936\u094d\u092f\u0915\u0924\u093e<\/h2>\n<p>\u0938\u0902\u0918\u0940\u092f \u0915\u093e\u0928\u0942\u0928 (\u092f\u0942\u090f\u0938\u090f) \u0907\u0938 \u0909\u092a\u0915\u0930\u0923 \u0915\u0940 \u092c\u093f\u0915\u094d\u0930\u0940 \u0915\u094b \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u0915 \u0926\u094d\u0935\u093e\u0930\u093e \u092f\u093e \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u0915 \u0915\u0947 \u0906\u0926\u0947\u0936 \u092a\u0930 \u0939\u0940 \u0938\u0940\u092e\u093f\u0924 \u0915\u0930\u0924\u093e \u0939\u0948\u0964<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">\u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u0915\u0947 \u0932\u093f\u090f<\/h2>\n<p>\u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u0939\u0947\u0924\u0941 \u091c\u093e\u0928\u0915\u093e\u0930\u0940 <a href=\"https:\/\/www.rigicon.us\/\" rel=\"noopener\">www.rigicon.us<\/a> \u092a\u0930 \u092a\u094d\u0930\u0915\u093e\u0936\u093f\u0924 \u0915\u0940 \u091c\u093e\u0924\u0940 \u0939\u0948\u0964<\/p>\n<p class=\"uk-text-meta\"><em>\u0905\u0902\u0924\u093f\u092e \u0938\u092e\u0940\u0915\u094d\u0937\u093e: 24 \u0938\u093f\u0924\u0902\u092c\u0930 2026\u0964<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Rigicon \u0915\u0947 \u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u0908 \u0926\u0947\u0936\u094b\u0902 \u092e\u0947\u0902 \u0935\u093f\u0924\u0930\u093f\u0924 \u0915\u093f\u090f \u091c\u093e\u0924\u0947 \u0939\u0948\u0902\u0964 \u0928\u093f\u092f\u093e\u092e\u0915 \u0938\u094d\u0925\u093f\u0924\u093f \u0914\u0930 \u0909\u092a\u0932\u092c\u094d\u0927\u0924\u093e \u0926\u0947\u0936 \u0915\u0947 \u0905\u0928\u0941\u0938\u093e\u0930 \u092d\u093f\u0928\u094d\u0928 \u0939\u094b\u0924\u0940 \u0939\u0948\u0964 \u092f\u0939 \u092a\u0943\u0937\u094d\u0920 \u0915\u0947\u0935\u0932 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u0915\u0940 \u0938\u094d\u0925\u093f\u0924\u093f \u0915\u093e \u0935\u0930\u094d\u0923\u0928 \u0915\u0930\u0924\u093e \u0939\u0948\u0964 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u092c\u093f\u0915\u094d\u0930\u0940 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u0932\u092c\u094d\u0927 \u0928\u0939\u0940\u0902 \u0909\u0924\u094d\u092a\u093e\u0926 Infla10&reg;, Infla2P&trade;, ContiReflex&reg;, ContiClassic&reg; \u0914\u0930 Testi10&trade; \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u092c\u093f\u0915\u094d\u0930\u0940 \u0915\u0947 \u0932\u093f\u090f [&hellip;]<\/p>\n","protected":false},"author":0,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-33091","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>\u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0928\u093f\u092f\u093e\u092e\u0915 \u0938\u094d\u0925\u093f\u0924\u093f - Rigicon<\/title>\n<meta name=\"description\" content=\"Rigicon \u0915\u0947 \u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u0908 \u0926\u0947\u0936\u094b\u0902 \u092e\u0947\u0902 \u0935\u093f\u0924\u0930\u093f\u0924 \u0915\u093f\u090f \u091c\u093e\u0924\u0947 \u0939\u0948\u0902\u0964 \u092f\u0939 \u092a\u0943\u0937\u094d\u0920 \u0915\u0947\u0935\u0932 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u0915\u0940 \u0938\u094d\u0925\u093f\u0924\u093f \u0915\u093e \u0935\u0930\u094d\u0923\u0928 \u0915\u0930\u0924\u093e \u0939\u0948\u0964\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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