Cleared Traditional

AMS LARGE PORE POLYPROPHLENE MESH

K121805 · American Medical Systems · Obstetrics & Gynecology

Oct 2012

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K121805 is an FDA 510(k) clearance for the AMS LARGE PORE POLYPROPHLENE MESH, a Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (Class II — Special Controls, product code OTO), submitted by American Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on October 16, 2012, 119 days after receiving the submission on June 19, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K121805 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2012
Decision Date	October 16, 2012
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	OTO — Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.