AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE— 510(k) K082677

Clearance details

Applicant

American Medical Systems, Inc.

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2008-09-15

Decision date

2008-12-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Minnetonka, MN, US

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• K103426 — LITE PELVIC FLOOR REPAIR KITS2011-09-14
• K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM2011-09-08

• K132655 — RETROARC RETROPUBIC SLING SYSTEM2013-11-20
• 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
• K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS2009-04-09

Injury

1,061

Total

1,061

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 →