{"id":33090,"date":"2026-09-24T02:53:57","date_gmt":"2026-09-24T06:53:57","guid":{"rendered":"https:\/\/www.rigicon.com\/us-regulatory-status-6\/"},"modified":"2026-09-24T03:33:00","modified_gmt":"2026-09-24T07:33:00","slug":"us-regulatory-status","status":"publish","type":"page","link":"https:\/\/www.rigicon.com\/ko\/us-regulatory-status\/","title":{"rendered":"\ubbf8\uad6d \uaddc\uc81c \ud604\ud669"},"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 \uc81c\ud488\uc740 \uc5ec\ub7ec \uad6d\uac00\uc5d0 \uacf5\uae09\ub429\ub2c8\ub2e4. \uaddc\uc81c \ud604\ud669\uacfc \uac00\uc6a9\uc131\uc740 \uad6d\uac00\ub9c8\ub2e4 \ub2e4\ub985\ub2c8\ub2e4. \uc774 \ud398\uc774\uc9c0\ub294 \ubbf8\uad6d\uc758 \ud604\ud669\ub9cc\uc744 \uc124\uba85\ud569\ub2c8\ub2e4.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">\ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\uc9c0 \uc54a\ub294 \uc81c\ud488<\/h2>\n<p>Infla10<sup>&reg;<\/sup>, Infla2P<sup>&trade;<\/sup>, ContiReflex<sup>&reg;<\/sup>, ContiClassic<sup>&reg;<\/sup> \ubc0f Testi10<sup>&trade;<\/sup>\uc740 \ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Rigi10<sup>&trade;<\/sup> \uad74\uace1\ud615 \uc74c\uacbd \ubcf4\ud615\ubb3c<\/h2>\n<p>Rigi10<sup>&trade;<\/sup> \uad74\uace1\ud615 \uc74c\uacbd \ubcf4\ud615\ubb3c\uc740 \ubbf8\uad6d\uc5d0\uc11c 9, 10, 11, 12, 13&nbsp;mm \uc9c1\uacbd\uc73c\ub85c \uc81c\uacf5\ub429\ub2c8\ub2e4. 14&nbsp;mm \uc0ac\uc774\uc988\ub294 \ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Infla10<sup>&reg;<\/sup> \u2014 \ubbf8\uad6d\uc5d0\uc11c \uc784\uc0c1\uc2dc\ud5d8\uc6a9 \uae30\uae30<\/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\">(\ubc95\uc815 \uace0\uc9c0\ubb38\uc758 \ubc88\uc5ed: \u201c\uc8fc\uc758 \u2014 \uc784\uc0c1\uc2dc\ud5d8\uc6a9 \uae30\uae30. \ubbf8\uad6d \uc5f0\ubc29\ubc95\uc5d0 \ub530\ub77c \uc5f0\uad6c \ubaa9\uc801 \uc0ac\uc6a9\uc73c\ub85c \uc81c\ud55c\ub428.\u201d \uc601\ubb38\uc774 \uc815\ubcf8\uc785\ub2c8\ub2e4.)<\/p>\n<p>\ubbf8\uad6d\uc5d0\uc11c Infla10<sup>&reg;<\/sup> Pulse<sup>&trade;<\/sup> Dynamic Inflatable Penile Prosthesis\ub294 \uc784\uc0c1\uc2dc\ud5d8\uc6a9 \uae30\uae30\uc785\ub2c8\ub2e4. FDA\uac00 \uc2b9\uc778\ud55c \uc784\uc0c1\uc2dc\ud5d8\uc6a9 \uae30\uae30 \uba74\uc81c(IDE)\uc5d0 \ub530\ub77c \uc218\ud589\ub418\ub294 \uc804\ud5a5\uc801\u00b7\ub2e4\uae30\uad00\u00b7\ub2e8\uc77c\uad70 \uc5f0\uad6c\uc778 UNITED \uc5f0\uad6c\uc5d0\uc11c \ud3c9\uac00\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. ClinicalTrials.gov \uc2dd\ubcc4\ubc88\ud638: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT07273773\" rel=\"noopener\">NCT07273773<\/a>.<\/p>\n<p>\uc774 \uae30\uae30\ub294 \ubbf8\uad6d \ub0b4 \uc0c1\uc5c5\uc801 \uc720\ud1b5\uc5d0 \ub300\ud574 FDA\uc758 \uc2b9\uc778\uc744 \ubc1b\uc9c0 \uc54a\uc558\uc2b5\ub2c8\ub2e4. \uc5f0\uad6c\uac00 \uc644\ub8cc\ub418\uace0 FDA\uac00 \uacb0\uacfc\ub97c \uac80\ud1a0\ud558\uae30 \uc804\uae4c\uc9c0\ub294 \uc5f0\uad6c \ub300\uc0c1 \uc6a9\ub3c4\uc5d0 \ub300\ud55c \uc548\uc804\uc131 \ub610\ub294 \uc720\ud6a8\uc131\uc5d0 \uad00\ud574 \uc5b4\ub5a0\ud55c \uacb0\ub860\ub3c4 \ub0b4\ub9b4 \uc218 \uc5c6\uc2b5\ub2c8\ub2e4.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">\ucc98\ubc29 \uc694\uac74<\/h2>\n<p>\ubbf8\uad6d \uc5f0\ubc29\ubc95\uc740 \uc774 \uae30\uae30\uc758 \ud310\ub9e4\ub97c \uc758\uc0ac\uc5d0 \uc758\ud558\uac70\ub098 \uc758\uc0ac\uc758 \uc9c0\uc2dc\uc5d0 \ub530\ub978 \uacbd\uc6b0\ub85c \uc81c\ud55c\ud569\ub2c8\ub2e4.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">\ubbf8\uad6d \uc774\uc6a9\uc790 \uc548\ub0b4<\/h2>\n<p>\ubbf8\uad6d\uc744 \ub300\uc0c1\uc73c\ub85c \ud55c \uc815\ubcf4\ub294 <a href=\"https:\/\/www.rigicon.us\/\" rel=\"noopener\">www.rigicon.us<\/a>\uc5d0 \uac8c\uc2dc\ub429\ub2c8\ub2e4.<\/p>\n<p class=\"uk-text-meta\"><em>\ucd5c\uc885 \uac80\ud1a0: 2026\ub144 9\uc6d4 24\uc77c.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Rigicon \uc81c\ud488\uc740 \uc5ec\ub7ec \uad6d\uac00\uc5d0 \uacf5\uae09\ub429\ub2c8\ub2e4. \uaddc\uc81c \ud604\ud669\uacfc \uac00\uc6a9\uc131\uc740 \uad6d\uac00\ub9c8\ub2e4 \ub2e4\ub985\ub2c8\ub2e4. \uc774 \ud398\uc774\uc9c0\ub294 \ubbf8\uad6d\uc758 \ud604\ud669\ub9cc\uc744 \uc124\uba85\ud569\ub2c8\ub2e4. \ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\uc9c0 \uc54a\ub294 \uc81c\ud488 Infla10&reg;, Infla2P&trade;, ContiReflex&reg;, ContiClassic&reg; \ubc0f Testi10&trade;\uc740 \ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. Rigi10&trade; \uad74\uace1\ud615 \uc74c\uacbd \ubcf4\ud615\ubb3c Rigi10&trade; \uad74\uace1\ud615 \uc74c\uacbd \ubcf4\ud615\ubb3c\uc740 \ubbf8\uad6d\uc5d0\uc11c 9, 10, 11, 12, 13&nbsp;mm \uc9c1\uacbd\uc73c\ub85c \uc81c\uacf5\ub429\ub2c8\ub2e4. 14&nbsp;mm \uc0ac\uc774\uc988\ub294 \ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. Infla10&reg; \u2014 \ubbf8\uad6d\uc5d0\uc11c \uc784\uc0c1\uc2dc\ud5d8\uc6a9 \uae30\uae30 CAUTION\u2014Investigational [&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-33090","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>\ubbf8\uad6d \uaddc\uc81c \ud604\ud669 - Rigicon<\/title>\n<meta name=\"description\" content=\"Rigicon \uc81c\ud488\uc740 \uc5ec\ub7ec \uad6d\uac00\uc5d0 \uacf5\uae09\ub429\ub2c8\ub2e4. \uaddc\uc81c \ud604\ud669\uacfc \uac00\uc6a9\uc131\uc740 \uad6d\uac00\ub9c8\ub2e4 \ub2e4\ub985\ub2c8\ub2e4. \uc774 \ud398\uc774\uc9c0\ub294 \ubbf8\uad6d\uc758 \ud604\ud669\ub9cc\uc744 \uc124\uba85\ud569\ub2c8\ub2e4.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rigicon.com\/ko\/us-regulatory-status\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\ubbf8\uad6d \uaddc\uc81c \ud604\ud669\" \/>\n<meta property=\"og:description\" content=\"Rigicon \uc81c\ud488\uc740 \uc5ec\ub7ec \uad6d\uac00\uc5d0 \uacf5\uae09\ub429\ub2c8\ub2e4. \uaddc\uc81c \ud604\ud669\uacfc \uac00\uc6a9\uc131\uc740 \uad6d\uac00\ub9c8\ub2e4 \ub2e4\ub985\ub2c8\ub2e4. \uc774 \ud398\uc774\uc9c0\ub294 \ubbf8\uad6d\uc758 \ud604\ud669\ub9cc\uc744 \uc124\uba85\ud569\ub2c8\ub2e4.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rigicon.com\/ko\/us-regulatory-status\/\" \/>\n<meta property=\"og:site_name\" content=\"Rigicon\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/rigiconurology\/\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-24T07:33:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.rigicon.com\/wp-content\/uploads\/2024\/07\/Logo-Square-Kopya.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"600\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@rigiconurology\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.rigicon.com\\\/ko\\\/us-regulatory-status\\\/\",\"url\":\"https:\\\/\\\/www.rigicon.com\\\/ko\\\/us-regulatory-status\\\/\",\"name\":\"\ubbf8\uad6d \uaddc\uc81c \ud604\ud669 - 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