510(k) · Cleared

Cleared

angiOCCLUDE Ligating Clips

K230966510(k) TraditionalCleared Sep 19, 2023167-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

A2 Medical Systems, LLC · FZP Clip, Implantable

Cleared on Sep 19, 2023 as substantially equivalent to K901303 (Horizon Surgical, Inc., 1990) and 1 other predicate after a 167-day review. Its family tree reaches back 1 generation to 1990.

Decided: Sep 19, 2023
Review: 167 days
Class: Class II
Product code: FZP
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K901303 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK901303 Horizon Surgical Ligating and Marking ClipHorizon Surgical, Inc. · 1990
This deviceK230966 angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901303	Horizon Surgical Ligating and Marking Clip	Horizon Surgical, Inc.	1990	—
0 (this device)	K230966	angiOCCLUDE Ligating Clips	A2 Medical Systems, LLC	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K230966, 1990–2023Source: 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? (2)

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
*	K901303	Horizon Surgical Ligating and Marking Clip Summary page 4 …roduct Codes: FZP per 878.4300 DSS per 870.3250 C. Predicate Devices Teleflex Medical Horizon Ligating Clips (510ks; K901303, K982313), Product Codes: DSS (870.3250) and FZP (878.4300) D. Clip Device Description AngiOCCLUDE ligating clips are per…	Horizon Surgical, Inc.	1990	—
*	K982313	Horizon Titanium Clips, Horizon Tantalum Clips Summary page 4 …des: FZP per 878.4300 DSS per 870.3250 C. Predicate Devices Teleflex Medical Horizon Ligating Clips (510ks; K901303, K982313), Product Codes: DSS (870.3250) and FZP (878.4300) D. Clip Device Description AngiOCCLUDE ligating clips are permanent im…	Weck Closure Systems	1998	1

Also cleared against K901303: 1 other device →

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 2 ancestors has a recall of any class.
1 other device also cites its predicate K901303.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

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?

angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures.

Surgeons should apply the appropriate size clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K230966 · printed Nov 6, 2026

Cite this page

510(k) Report. “K230966: angiOCCLUDE Ligating Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230966

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026