AMS MALE TRANSOBTURATOR SLING SYSTEM— 510(k) K053371

Clearance details

Applicant

American Medical Systems, Inc.

Product code

Code OTM

Device class

Class 2

Regulation

21 CFR 878.3300

Advisory panel

General, Plastic Surgery

Date received

2005-12-05

Decision date

2006-02-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minnetonka, MN, US

• K242960 — AdVance XP Male Sling System (720163-03)2024-11-15
• K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit2023-09-25
• K211847 — AdVance XP Male Sling System2021-12-20
• K182169 — AdVance XP Male Sling2018-11-27
• K113496 — VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT2012-02-14

• K132655 — RETROARC RETROPUBIC SLING SYSTEM2013-11-20
• K112842 — AMS ELEVATE PC2011-10-25
• K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 7201912010-06-07
• K092735 — GREENLIGHT XPS LASER SYSTEM2009-11-09
• K090934 — PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM2009-06-02

Injury

760

Total

760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0806-2015 — AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One end of each helical needle passer is keyed to allow a secure attachment of the sling connectors. The sling mesh is constructed of polypropylene monofilament mesh that is precut to 1.2 centimeters arm width, 3.55 centimeters center width, and 35.5 centimeters length. Two absorbable tensioning sutures are threaded into the length of the mesh. Plastic sheaths are placed over each arm of the mesh to aide in ease of placement. The connectors are attached to the ends of the helical needle passers during the procedure. The mesh and suture portions of the sling are intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.Class II·Terminated·American Medical Systems, Inc.·20141015
• Z-0259-2013 — AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).Class II·Terminated·American Medical Systems, Inc.·20121019

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053371.