510(k) · Cleared

Cleared

Implantable Clip

K933887510(k) TraditionalCleared Nov 24, 1993106-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

United States Surgical, A Division of Tyco Healthc · FZP Clip, Implantable

Cleared on Nov 24, 1993 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 62 later devices descend from it.

Decided: Nov 24, 1993
Review: 106 days
Class: Class II
Product code: FZP
Recalls: None
Predicates: 0

62 later devices descend from it, 2 citing it directly.

This deviceK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
Descendant · cites it directly · 58 of its ownK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
Descendant · 2 generations on · 55 of its ownK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
Descendant · 3 generations on · 52 of its ownK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
Descendant · 4 generations on · 44 of its ownK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
Descendant · 5 generations on · 43 of its ownK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

1996high 6 (2004) · low 0 (1997)2026

Most influential descendants

Showing 5 of 62 · See all

K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · cites it directly58descendants
K994160Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000 · 2 generations on55descendants
K012317Coalescent Surgical U-ClipCoalescent Surgical · 2001 · 3 generations on52descendants
K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002 · 4 generations on44descendants
K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002 · 5 generations on43descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K933887	Implantable Clip	United States Surgical, A Division of Tyco Healthc	1993	—
+1	K962043	Auto Suture Modified VCS Clip Applier	United States Surgical, A Division of Tyco Healthc	1996	7
+2	K994160	Coalescent Surgical Sutured-Clip	Coalescent Surgical	2000	—
+3	K012317	Coalescent Surgical U-Clip	Coalescent Surgical	2001	—
+4	K013664	Coalescent Surgical U-Clip	Coalescent Surgical	2002	—
+5	K021407	Coalescent Surgical U-Clip - or Other TBD and Accessories	Coalescent Surgical	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2000	1	0
2001	3	0
2002	4	0
2003	2	0
2004	6	0
2005	3	0
2006	4	0
2007	4	0
2008	1	0
2009	1	0
2010	3	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2015	3	0
2016	3	0
2017	3	0
2018	3	0
2019	1	0
2020	1	0
2021	1	0
2022	3	0
2023	2	0
2024	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K933887, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (62)

See all 62

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K962043	Auto Suture Modified VCS Clip Applier	United States Surgical, A Division of Tyco Healthc	1996	58
K011589	Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to…	Bypass, Ltd.	2001	2

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?

Of its descendants, K962043 (United States Surgical, A Division of Tyco Healthc, 1996) has gone furthest, with 58 descendants of its own.

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	—

https://510kreport.com/device/K933887 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933887: Implantable Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933887

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026