510(k) Report

510(k) · Cleared

Cleared

Coalescent Surgical U-Clip - or Other TBD and Accessories

K021407510(k) TraditionalCleared Jul 3, 200261-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

Coalescent Surgical · FZP Clip, Implantable

Cleared on Jul 3, 2002 as substantially equivalent to K013664 (Coalescent Surgical, 2002) after a 61-day review. Its family tree reaches back 5 generations to 1993. 43 later devices descend from it.

Decided
Jul 3, 2002
Review
61 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K933887 (1993). 10 ancestors in all, the oldest K771412 (1977). 43 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor1997: 2 other ancestors1977: 1 other ancestor2008: 1 descendant cleared2005: 3 descendants cleared2004: 4 descendants cleared2003: 2 descendants cleared2002: 1 descendant cleared2006: 4 descendants cleared2010: 2 descendants cleared2007: 4 descendants cleared2015: 1 descendant cleared2017: 3 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2025: 1 descendant cleared2011: 1 descendant cleared2009: 1 descendant cleared2016: 2 descendants cleared2026: 3 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant clearedK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000×2: 2 generations cleared close together, K012317 (2001), K013664 (2002) 19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 4 descendants3 generations forward: 10 descendants4 generations forward: 9 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant10 generations forward: 3 descendants11 generations forward: 2 descendants K013664 · Coalescent Surgical U-Clip · Coalescent Surgical · 2002K012317 · Coalescent Surgical U-Clip · Coalescent Surgical · 2001K994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993−50+5+10
  1. Root · 5 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 4 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
  3. 3 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  4. 2 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  5. 1 generation backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  6. This deviceK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  7. Descendant · cites it directly · 42 of its ownK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  8. Descendant · cites it directly · 41 of its ownK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  9. Descendant · cites it directly · 32 of its ownK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  10. Descendant · 2 generations on · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
  11. Descendant · 3 generations on · 15 of its ownK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22004: 42005: 32006: 42007: 42008: 12009: 12010: 22011: 12012: 12013: 12014: 12015: 12016: 22017: 32018: 22019: 12021: 12022: 12023: 22025: 12026: 3
2002high 4 (2004) · low 0 (2020)2026

Most influential descendants

Showing 5 of 43 · See all
  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002 · cites it directly42descendants
  • K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · cites it directly41descendants
  • K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · cites it directly32descendants
  • K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc. · 2010 · 2 generations on18descendants
  • K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012 · 3 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K933887Implantable ClipUnited States Surgical, A Division of Tyco Healthc1993—
−4K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc19967
−3K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
−2K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
−1K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
0 (this device)K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
+1K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical2002—
+1K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20031
+1K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20034
+2K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc.2010—
+3K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
199720
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200440
200530
200640
200740
200810
200910
201020
201110
201210
201310
201410
201510
201620
201730
201820
201910
202110
202210
202320
202510
202630
FIG. 1 — Lineage of K021407, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K013664Coalescent Surgical U-ClipCoalescent Surgical2002—

Also cleared against K013664: 8 other devices →

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical200242
K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical200341
K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical200332
K062057U-Clip Device, Model NC65Medtronic Vascular20062
K053252U-Clip Device, Models B140, B160 and B180Medtronic Vascular20051
K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080
K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20040

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?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K023125 (Coalescent Surgical, 2002) has gone furthest, with 42 descendants of its own.
  • 8 other devices also cite its predicate K013664.

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

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

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

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
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

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—

What is it indicated for?

The Coalescent Surgical U-CLIPTM is intended for endoscopic and non-endoscopic tissue

and prosthetic material approximatiodattachent and the creation of anastomoses in

blood vessels, grafts and other tubular structures; including use in cardiovascular and

coronary artery bypass grafting procedures.

Indications for use as stated in the FDA summary.

Also cleared against K013664

8 other devices cite the same predicate.

  • K081082U-Clip Uni-Fire, Model M65Medtronic, Inc. · 2008
  • K062821U-Clip DeviceMedtronic Neurosurgery · 2006
  • K062057U-Clip Device, Model NC65Medtronic Vascular · 2006
  • K053252U-Clip Device, Models B140, B160 and B180Medtronic Vascular · 2005
  • K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2004
  • K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 20034 recalls

More from Coalescent Surgical

9 FDA decisions under this applicant name. See the company

  • K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2004
  • K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 20034 recalls
  • K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 20031 recall
  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  • K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002

Recent decisions in FZP

The FZP category page

  • K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

https://510kreport.com/device/K021407 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021407

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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