510(k) K053371 ยท OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
AMS MALE TRANSOBTURATOR SLING SYSTEM
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 3, 2006 |
| Received | Dec 5, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | American Medical Systems, Inc. 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 surgic Terminated |
OTM | None listed |
| Nov 7, 2012 | American Medical Systems, Inc. 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 Syste Terminated |
FTL | None listed |
| Dec 27, 2010 | American Medical Systems, Inc. Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL.
Sterilization Method ETO, American Medical Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.