AMS SOFT-TISSUE APPROXIMATION SYSTEM— 510(k) K012342

Clearance details

Applicant

American Medical Systems, Inc.

Product code

Code FZP

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2001-07-24

Decision date

2001-09-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minnetonka, MN, US

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Death

11

Injury

726

Malfunction

10,830

Other

1

Total

11,568

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 →