Cleared Traditional

K121805 - AMS LARGE PORE POLYPROPHLENE MESH

K121805 is an FDA 510(k) clearance for AMS LARGE PORE POLYPROPHLENE MESH, manufactured by American Medical Systems. The device is a Class 2 Obstetrics & Gynecology device with product code OTO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K121805 · American Medical Systems · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
119d
Days
Class 2
Risk

K121805 is an FDA 510(k) clearance for the AMS LARGE PORE POLYPROPHLENE MESH. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (product code OTO), Class II - Special Controls.

Submitted by American Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on October 16, 2012 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 878.3300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Systems devices

FDA 510(k) Submission Details - K121805

510(k) Number K121805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 160d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTO Device Classification - Class 2, Special Controls

Product Code OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

All 13
Devices cleared under the same product code (OTO) and FDA review panel - the closest regulatory comparables to K121805.
UPSYLON Y MESH
K122794 · Boston Scientific Corp · Dec 2012
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
K122968 · Coloplast Corp. · Dec 2012
RESTORELLE L
K122440 · Coloplast Corp. · Nov 2012
ARTISYN Y-SHAPED MESH
K113205 · Ethicon, Inc. · Jun 2012
RESTORELLE POLYPROPYLENE Y MESH
K112322 · Coloplast A/S · May 2012
ALYTE Y-MESH GRAFT
K101722 · C.R. Bard, Inc. · Apr 2011