510(k) Report

510(k) · Cleared

Cleared

Coalescent Surgical U-Clip and Accessories

K040821510(k) TraditionalCleared Apr 23, 200424-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 Apr 23, 2004 as substantially equivalent to K031623 (Coalescent Surgical, 2003) and 7 other predicates after a 24-day review. Its family tree reaches back 9 generations to 1993.

Decided
Apr 23, 2004
Review
24 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
8

Its longest line of descent runs back 9 generations to K933887 (1993). 15 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1977: 1 other ancestorK933887 · 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 · 2000K012317 · Coalescent Surgical U-Clip · Coalescent Surgical · 2001K013664 · Coalescent Surgical U-Clip · Coalescent Surgical · 2002K021407 · Coalescent Surgical U-Clip - or Other TBD and Accessories · Coalescent Surgical · 2002×2: 2 generations cleared close together, K023125 (2002), K024366 (2003) K031623 · Modification to Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalled1975198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 1 other ancestor K031623 · Modification to Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK024366 · Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK023125 · Coalescent U-Clip- and Accessories · Coalescent Surgical · 2002K021407 · 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
  1. Root · 9 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 5 generations between
  3. 3 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  4. 2 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  5. 1 generation backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  6. This deviceK040821 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2004
Show all 9 generations
  1. Root · 9 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 8 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
  3. 7 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  4. 6 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  5. 5 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  6. 4 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  7. 3 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  8. 2 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  9. 1 generation backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  10. This deviceK040821 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K933887Implantable ClipUnited States Surgical, A Division of Tyco Healthc1993—
−8K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc19967
−7K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
−6K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
−5K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
−4K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
−3K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical2002—
−2K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20031
−1K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20034
0 (this device)K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
199510
199720
200010
200110
FIG. 1 — Lineage of K040821, 1993–2004Source: 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
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What was it cleared against? (8)

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
*K031623Modification to Coalescent Surgical U-Clip and Accessories
Summary page 1
…equivalent in intended use (although restricted in this submission), fabrication and design to the following predicate device: * Coalescent Surgical U-CLIPTM - K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588 Device Description: The Coalescent Surgical PG-…
Coalescent Surgical20034
*K024366Coalescent Surgical U-Clip and Accessories
Summary page 1
…t in intended use (although restricted in this submission), fabrication and design to the following predicate device: * Coalescent Surgical U-CLIPTM - K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588 Device Description: The Coalescent Surgical PG-CLIPTm de…
Coalescent Surgical20031
*K023125Coalescent U-Clip- and Accessories
Summary page 1
…nded use (although restricted in this submission), fabrication and design to the following predicate device: * Coalescent Surgical U-CLIPTM - K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588 Device Description: The Coalescent Surgical PG-CLIPTm device is a…
Coalescent Surgical2002—
*K021407Coalescent Surgical U-Clip - or Other TBD and Accessories
Summary page 1
…(although restricted in this submission), fabrication and design to the following predicate device: * Coalescent Surgical U-CLIPTM - K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588 Device Description: The Coalescent Surgical PG-CLIPTm device is a self-clo…
Coalescent Surgical2002—
*K013664Coalescent Surgical U-Clip
Summary page 1
…h restricted in this submission), fabrication and design to the following predicate device: * Coalescent Surgical U-CLIPTM - K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588 Device Description: The Coalescent Surgical PG-CLIPTm device is a self-closing clip…
Coalescent Surgical2002—
*K012317Coalescent Surgical U-Clip
Summary page 1
…submission), fabrication and design to the following predicate device: * Coalescent Surgical U-CLIPTM - K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588 Device Description: The Coalescent Surgical PG-CLIPTm device is a self-closing clip for peripheral vasc…
Coalescent Surgical2001—
*K994160Coalescent Surgical Sutured-Clip
Summary page 1
…on), fabrication and design to the following predicate device: * Coalescent Surgical U-CLIPTM - K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588 Device Description: The Coalescent Surgical PG-CLIPTm device is a self-closing clip for peripheral vascular ana…
Coalescent Surgical2000—
*K971588Evi Sutured-Clip Applier
Summary page 1
…ion and design to the following predicate device: * Coalescent Surgical U-CLIPTM - K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588 Device Description: The Coalescent Surgical PG-CLIPTm device is a self-closing clip for peripheral vascular anastomosis and…
Elective Vascular Intervention Inc. (Evi)1997—

Also cleared against K031623: 4 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?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • 4 of the 15 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K031623.

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 PG-CLIPTM and accessories are intended for endoscopic and non-endoscopic peripheral vascular and general surgical soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in peripheral vascular blood vessels, grafts and other tubular structures. The PG-CLIP is not intended for use in cardiac and/or thoracic procedures; including, but not limited to intra-cardiac and coronary artery bypass grafting (CABG) procedures.

Indications for use as stated in the FDA summary.

Also cleared against K031623

4 other devices cite the same predicate.

  • K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model…AtriCure, Inc. · 2010
  • K062057U-Clip Device, Model NC65Medtronic Vascular · 2006
  • K053252U-Clip Device, Models B140, B160 and B180Medtronic Vascular · 2005
  • K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050Cardica, Inc. · 2005

More from Coalescent Surgical

9 FDA decisions under this applicant name. See the company

  • 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
  • K021407Coalescent Surgical U-Clip - or Other TBD 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/K040821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040821: Coalescent Surgical U-Clip 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/K040821

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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