510(k) Report

510(k) · Cleared

Cleared

Coalescent U-Clip- and Accessories

K023125510(k) TraditionalCleared Dec 18, 200290-day reviewClass II21 CFR 878.4495

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

Coalescent Surgical · NJU Suture, Nonabsorbable, Nitinol

Cleared on Dec 18, 2002 as substantially equivalent to K021407 (Coalescent Surgical, 2002) and 5 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1993. 42 later devices descend from it.

Decided
Dec 18, 2002
Review
90 days
Class
Class II
Product code
NJU
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K933887 (1993). 12 ancestors in all, the oldest K771412 (1977). 42 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 2 other ancestors1995: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1977: 1 other ancestor2008: 1 descendant cleared2005: 3 descendants cleared2004: 4 descendants cleared2003: 2 descendants 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 · 2000×3: 3 generations cleared close together, K012317 (2001), K013664 (2002), K021407 (2002) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 6 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 K021407 · Coalescent Surgical U-Clip - or Other TBD and Accessories · Coalescent Surgical · 2002K013664 · 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 · 6 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 5 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
  3. 4 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  4. 3 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  5. 2 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  6. 1 generation backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  7. This deviceK023125 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
  12. Descendant · 4 generations on · 10 of its ownK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2003: 22004: 42005: 32006: 42007: 42008: 12009: 12010: 22011: 12012: 12013: 12014: 12015: 12016: 22017: 32018: 22019: 12021: 12022: 12023: 22025: 12026: 3
2003high 4 (2004) · low 0 (2020)2026

Most influential descendants

Showing 5 of 42 · See all
  • 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
  • K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc. · 2016 · 4 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K933887Implantable ClipUnited States Surgical, A Division of Tyco Healthc1993—
−5K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc19967
−4K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
−3K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
−2K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
−1K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
0 (this device)K023125Coalescent 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—
+4K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
199510
199720
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K023125, 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 NJU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (6)

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
*K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
*K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
*K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
*K994160Coalescent Surgical Sutured-Clip
Summary page 1
…s is substantially equivalent in intended use, fabrication and design to the following predicate device: 0 Coalescent Surgical U-CLIPTM - KO2 1407, KO 13664, KO 12317, K994 160 and K971588 0 Ethicon Stainless Steel, Gut, Poly suture - K946 173 (GAQ)…
Coalescent Surgical2000—
*K971588Evi Sutured-Clip Applier
Summary page 1
…ication and design to the following predicate device: 0 Coalescent Surgical U-CLIPTM - KO2 1407, KO 13664, KO 12317, K994 160 and K971588 0 Ethicon Stainless Steel, Gut, Poly suture - K946 173 (GAQ) 5 1O( k) SUMMARY (Continued) Device Description…
Elective Vascular Intervention Inc. (Evi)1997—
*K946173Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…
Summary page 1
…Coalescent Surgical U-CLIPTM - KO2 1407, KO 13664, KO 12317, K994 160 and K971588 0 Ethicon Stainless Steel, Gut, Poly suture - K946 173 (GAQ) 5 1O( k) SUMMARY (Continued) Device Description: The Coalescent Surgical U-CLIPTMdevice is a single sel…
ETHICON, Inc.199510

Also cleared against K021407: 6 other devices →

What descends from it? (42)

See all 42

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

NumberDeviceApplicantDecidedDescendants
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.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K024366 (Coalescent Surgical, 2003) has gone furthest, with 41 descendants of its own.
  • 6 other devices also cite its predicate K021407.

How does its category compare?

All NJU devices

NJU Suture, Nonabsorbable, Nitinol: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NJU

FDA has decided no NJU device since 2007.

Median 510(k) review, days · NJU

Too few NJU 510(k)s in any year since 2007 to give a median.

Recalls per year · NJU

No recall names NJU since 2007.

Adverse event reports per year · NJU

No MAUDE report names NJU since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Coalescent Surgical U-CLIPTM and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.

Indications for use as stated in the FDA summary.

Also cleared against K021407

6 other devices cite the same predicate.

  • K081082U-Clip Uni-Fire, Model M65Medtronic, Inc. · 2008
  • 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
  • K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 20031 recall

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
  • K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  • K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002

Recent decisions in NJU

The NJU category page

  • K023372Non-Bioabsorbable StapleOnux Medical, Inc. · 2002

https://510kreport.com/device/K023125 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023125: Coalescent U-Clip- and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023125

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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