# K012342: Ams Soft-Tissue Approximation System

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Sep 5, 2001 after 43 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925573 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942442: Acufex T-Fix Delivery System, Acufex Microsurgical, Inc. (1994) Summary page 1.
- K925573: Acufex T-Bar, Acufex Microsurgical, Inc. (1993) Summary page 1.
- K010277: Ams Fascial-Anchoring System, American Medical Systems, Inc. (2001) Summary page 1.

## Indications for use
The AMS Soft Tissue Approximation system is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.

Source page: https://510kreport.com/device/K012342
Methodology: https://510kreport.com/methodology