{"id":33088,"date":"2026-09-24T02:53:57","date_gmt":"2026-09-24T06:53:57","guid":{"rendered":"https:\/\/www.rigicon.com\/us-regulatory-status-4\/"},"modified":"2026-09-24T03:32:50","modified_gmt":"2026-09-24T07:32:50","slug":"us-regulatory-status","status":"publish","type":"page","link":"https:\/\/www.rigicon.com\/pt-br\/us-regulatory-status\/","title":{"rendered":"Situa\u00e7\u00e3o regulat\u00f3ria nos Estados Unidos"},"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\">Os produtos da Rigicon s\u00e3o distribu\u00eddos em diversos pa\u00edses. A situa\u00e7\u00e3o regulat\u00f3ria e a disponibilidade variam de pa\u00eds para pa\u00eds. Esta p\u00e1gina descreve apenas a situa\u00e7\u00e3o nos Estados Unidos.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Produtos n\u00e3o dispon\u00edveis para venda nos Estados Unidos<\/h2>\n<p>Infla10<sup>&reg;<\/sup>, Infla2P<sup>&trade;<\/sup>, ContiReflex<sup>&reg;<\/sup>, ContiClassic<sup>&reg;<\/sup> e Testi10<sup>&trade;<\/sup> n\u00e3o est\u00e3o dispon\u00edveis para venda nos Estados Unidos.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Pr\u00f3tese Peniana Male\u00e1vel Rigi10<sup>&trade;<\/sup><\/h2>\n<p>A Pr\u00f3tese Peniana Male\u00e1vel Rigi10<sup>&trade;<\/sup> est\u00e1 dispon\u00edvel nos Estados Unidos nos di\u00e2metros de 9, 10, 11, 12 e 13&nbsp;mm. O tamanho de 14&nbsp;mm n\u00e3o est\u00e1 dispon\u00edvel para venda nos Estados Unidos.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Infla10<sup>&reg;<\/sup> \u2014 em investiga\u00e7\u00e3o nos Estados Unidos<\/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\">(Tradu\u00e7\u00e3o do aviso exigido por lei: \u00abATEN\u00c7\u00c3O \u2014 Dispositivo em investiga\u00e7\u00e3o. A lei federal (dos Estados Unidos) limita seu uso a fins de investiga\u00e7\u00e3o.\u00bb O texto em ingl\u00eas \u00e9 o que prevalece.)<\/p>\n<p>Nos Estados Unidos, a Infla10<sup>&reg;<\/sup> Pulse<sup>&trade;<\/sup> Dynamic Inflatable Penile Prosthesis \u00e9 um dispositivo em investiga\u00e7\u00e3o. Ela est\u00e1 sendo avaliada no estudo UNITED, um estudo prospectivo, multic\u00eantrico e de bra\u00e7o \u00fanico conduzido sob uma Isen\u00e7\u00e3o de Dispositivo em Investiga\u00e7\u00e3o (IDE) aprovada pela FDA. Identificador do ClinicalTrials.gov: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT07273773\" rel=\"noopener\">NCT07273773<\/a>.<\/p>\n<p>O dispositivo n\u00e3o \u00e9 aprovado pela FDA para distribui\u00e7\u00e3o comercial nos Estados Unidos. Nenhuma conclus\u00e3o sobre sua seguran\u00e7a ou efic\u00e1cia para o uso investigado pode ser tirada at\u00e9 que o estudo seja conclu\u00eddo e os resultados revisados pela FDA.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Exig\u00eancia de prescri\u00e7\u00e3o<\/h2>\n<p>A lei federal (EUA) restringe a venda deste dispositivo a m\u00e9dicos ou mediante prescri\u00e7\u00e3o m\u00e9dica.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Para os Estados Unidos<\/h2>\n<p>As informa\u00e7\u00f5es destinadas aos Estados Unidos s\u00e3o publicadas em <a href=\"https:\/\/www.rigicon.us\/\" rel=\"noopener\">www.rigicon.us<\/a>.<\/p>\n<p class=\"uk-text-meta\"><em>\u00daltima revis\u00e3o: 24 de setembro de 2026.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Os produtos da Rigicon s\u00e3o distribu\u00eddos em diversos pa\u00edses. A situa\u00e7\u00e3o regulat\u00f3ria e a disponibilidade variam de pa\u00eds para pa\u00eds. Esta p\u00e1gina descreve apenas a situa\u00e7\u00e3o nos Estados Unidos. Produtos n\u00e3o dispon\u00edveis para venda nos Estados Unidos Infla10&reg;, Infla2P&trade;, ContiReflex&reg;, ContiClassic&reg; e Testi10&trade; n\u00e3o est\u00e3o dispon\u00edveis para venda nos Estados Unidos. Pr\u00f3tese Peniana Male\u00e1vel Rigi10&trade; [&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-33088","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>Situa\u00e7\u00e3o regulat\u00f3ria nos Estados Unidos - Rigicon<\/title>\n<meta name=\"description\" content=\"Os produtos da Rigicon s\u00e3o distribu\u00eddos em diversos pa\u00edses. 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