{"id":33087,"date":"2026-09-24T02:53:57","date_gmt":"2026-09-24T06:53:57","guid":{"rendered":"https:\/\/www.rigicon.com\/us-regulatory-status-3\/"},"modified":"2026-09-24T03:32:45","modified_gmt":"2026-09-24T07:32:45","slug":"us-regulatory-status","status":"publish","type":"page","link":"https:\/\/www.rigicon.com\/es\/us-regulatory-status\/","title":{"rendered":"Situaci\u00f3n regulatoria en los 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\">Los productos de Rigicon se distribuyen en varios pa\u00edses. La situaci\u00f3n regulatoria y la disponibilidad var\u00edan de un pa\u00eds a otro. Esta p\u00e1gina describe \u00fanicamente la situaci\u00f3n en los Estados Unidos.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Productos no disponibles para la venta en los Estados Unidos<\/h2>\n<p>Infla10<sup>&reg;<\/sup>, Infla2P<sup>&trade;<\/sup>, ContiReflex<sup>&reg;<\/sup>, ContiClassic<sup>&reg;<\/sup> y Testi10<sup>&trade;<\/sup> no est\u00e1n disponibles para la venta en los Estados Unidos.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Pr\u00f3tesis Peniana Maleable Rigi10<sup>&trade;<\/sup><\/h2>\n<p>La Pr\u00f3tesis Peniana Maleable Rigi10<sup>&trade;<\/sup> est\u00e1 disponible en los Estados Unidos en di\u00e1metros de 9, 10, 11, 12 y 13&nbsp;mm. El tama\u00f1o de 14&nbsp;mm no est\u00e1 disponible para la venta en los Estados Unidos.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Infla10<sup>&reg;<\/sup> \u2014 en investigaci\u00f3n en los 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\">(Traducci\u00f3n del aviso exigido por la ley: \u00abPRECAUCI\u00d3N \u2014 Dispositivo en investigaci\u00f3n. La ley federal (de los Estados Unidos) limita su uso a fines de investigaci\u00f3n\u00bb. El texto en ingl\u00e9s es el que prevalece.)<\/p>\n<p>En los Estados Unidos, la Infla10<sup>&reg;<\/sup> Pulse<sup>&trade;<\/sup> Dynamic Inflatable Penile Prosthesis es un dispositivo en investigaci\u00f3n. Se est\u00e1 evaluando en el estudio UNITED, un estudio prospectivo, multic\u00e9ntrico y de un solo grupo realizado bajo una Exenci\u00f3n de Dispositivo en Investigaci\u00f3n (IDE) aprobada por la FDA. Identificador de ClinicalTrials.gov: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT07273773\" rel=\"noopener\">NCT07273773<\/a>.<\/p>\n<p>El dispositivo no est\u00e1 aprobado por la FDA para su distribuci\u00f3n comercial en los Estados Unidos. No puede extraerse ninguna conclusi\u00f3n sobre su seguridad o eficacia para el uso investigado hasta que el estudio haya concluido y la FDA haya revisado los resultados.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Requisito de prescripci\u00f3n<\/h2>\n<p>La ley federal (EE.&nbsp;UU.) restringe la venta de este dispositivo a m\u00e9dicos o por prescripci\u00f3n facultativa.<\/p>\n<h2 class=\"uk-h3 uk-margin-medium-top\">Para los Estados Unidos<\/h2>\n<p>La informaci\u00f3n dirigida a los Estados Unidos se publica en <a href=\"https:\/\/www.rigicon.us\/\" rel=\"noopener\">www.rigicon.us<\/a>.<\/p>\n<p class=\"uk-text-meta\"><em>\u00daltima revisi\u00f3n: 24 de septiembre de 2026.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Los productos de Rigicon se distribuyen en varios pa\u00edses. La situaci\u00f3n regulatoria y la disponibilidad var\u00edan de un pa\u00eds a otro. Esta p\u00e1gina describe \u00fanicamente la situaci\u00f3n en los Estados Unidos. Productos no disponibles para la venta en los Estados Unidos Infla10&reg;, Infla2P&trade;, ContiReflex&reg;, ContiClassic&reg; y Testi10&trade; no est\u00e1n disponibles para la venta en los [&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-33087","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>Situaci\u00f3n regulatoria en los Estados Unidos - Rigicon<\/title>\n<meta name=\"description\" content=\"Los productos de Rigicon se distribuyen en varios pa\u00edses. 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