510(k) · Cleared

Cleared

Ams Soft-Tissue Approximation System

K012342510(k) TraditionalCleared Sep 5, 200143-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

American Medical Systems, Inc. · FZP Clip, Implantable

Cleared on Sep 5, 2001 as substantially equivalent to K942442 (Acufex Microsurgical, Inc., 1994) and 2 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1993.

Decided: Sep 5, 2001
Review: 43 days
Class: Class II
Product code: FZP
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K925573 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
This deviceK012342 Ams Soft-Tissue Approximation SystemAmerican Medical Systems, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925573	Acufex T-Bar	Acufex Microsurgical, Inc.	1993	1
0 (this device)	K012342	Ams Soft-Tissue Approximation System	American Medical Systems, Inc.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
2001	1	0

FIG. 1 — Lineage of K012342, 1993–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FZP device

#1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K942442	Acufex T-Fix Delivery System Summary page 1 …157 Trade Name: AMS Soft Tissue Approximation System Classification Name: Implantable Clip and Applicator Predicate Devices: Acufex Microsurgical’s T-Fix and T-Bar (K942442 and K925573, respectively) and AMS In¢’s Fascial-Anchoring System (K010277). Indication for Use: The AMS soft tissue approximat…	Acufex Microsurgical, Inc.	1994	—
*	K925573	Acufex T-Bar Summary page 1 …ame: AMS Soft Tissue Approximation System Classification Name: Implantable Clip and Applicator Predicate Devices: Acufex Microsurgical’s T-Fix and T-Bar (K942442 and K925573, respectively) and AMS In¢’s Fascial-Anchoring System (K010277). Indication for Use: The AMS soft tissue approximation system (…	Acufex Microsurgical, Inc.	1993	1
*	K010277	Ams Fascial-Anchoring System Summary page 1 …Implantable Clip and Applicator Predicate Devices: Acufex Microsurgical’s T-Fix and T-Bar (K942442 and K925573, respectively) and AMS In¢’s Fascial-Anchoring System (K010277). Indication for Use: The AMS soft tissue approximation system (“ASTA™) is intended for use as a general use suture retention d…	American Medical Systems, Inc.	2001	—

Also cleared against K942442: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K942442.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZP

5in 2025

2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007high 227 (2022) · low 22 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FZP

1in 2020

2007high 6 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FZP

1,902in 2025

2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	31	1	1,877
2008	4	23	6	981
2009	3	22	0	2,160
2010	6	47	1	2,367
2011	3	124	0	1,678
2012	2	—	1	1,677
2013	3	47	0	2,381
2014	3	29	1	2,320
2015	8	182	0	2,871
2016	5	72	2	1,840
2017	4	29	1	2,594
2018	4	143	0	2,718
2019	1	—	3	2,903
2020	2	—	1	1,760
2021	0	—	0	1,759
2022	3	227	0	1,575
2023	3	65	0	1,918
2024	2	—	0	2,067
2025	5	90	0	1,902
2026	2	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012342 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012342: Ams Soft-Tissue Approximation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012342

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026