510(k) · Cleared
Recalled · 2005Coalescent Surgical U-Clip and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coalescent Surgical · FZP Clip, Implantable
Cleared on Jan 17, 2003 as substantially equivalent to K023125 (Coalescent Surgical, 2002) and 5 other predicates after a 17-day review. Its family tree reaches back 7 generations to 1993. 41 later devices descend from it. It has been recalled once.
- Decided
- Jan 17, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 7 generations to K933887 (1993). 13 ancestors in all, the oldest K771412 (1977). 41 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 6 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 5 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 4 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 3 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 2 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 1 generation backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- This deviceK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003
- Descendant · cites it directly · 32 of its ownK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- Descendant · 2 generations on · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- Descendant · 3 generations on · 15 of its ownK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
- Descendant · 4 generations on · 10 of its ownK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016
- Descendant · 5 generations on · 9 of its ownK173031 AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- 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
- K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −6 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −5 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −4 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −3 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −2 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −1 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| 0 (this device) | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | — |
| +1 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
| +2 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
| +3 | K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | 2012 | — |
| +4 | K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip | AtriCure, Inc. | 2016 | — |
| +5 | K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V Clip | AtriCure, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023125 | Coalescent U-Clip- and Accessories | 2002 |
| * | K021407 | Coalescent Surgical U-Clip - or Other TBD and AccessoriesSummary page 2…procedures. Comparison to Predicate Device(s): The Coalescent Surgical U-CLIPTMand accessories is substantially equivalent to the Coalescent Surgical U-CLIP K02312.5, K021407, K013664, KO12317, K994160 and K971588 in terms of materials, use and application. Test Data: In vitro and in vivo data have co… | 2002 |
| * | K013664 | Coalescent Surgical U-ClipSummary page 2…es. Comparison to Predicate Device(s): The Coalescent Surgical U-CLIPTMand accessories is substantially equivalent to the Coalescent Surgical U-CLIP K02312.5, K021407, K013664, KO12317, K994160 and K971588 in terms of materials, use and application. Test Data: In vitro and in vivo data have confirmed t… | 2002 |
| * | K012317 | Coalescent Surgical U-Clip | 2001 |
| * | K994160 | Coalescent Surgical Sutured-ClipSummary page 1…tially equivalent in intended use, fabrication and design to the following predicate device: Coalescent Surgical U-CLIPTM- KO23 125, KO2 1407, KO 13664, KO 12317, K994 160, and K971588 Device Description: The Coalescent Surgical U-CLIPTMdevice is a self-closing clip for vascular anastomosis… | 2000 |
| * | K971588 | Evi Sutured-Clip ApplierSummary page 1…intended use, fabrication and design to the following predicate device: Coalescent Surgical U-CLIPTM- KO23 125, KO2 1407, KO 13664, KO 12317, K994 160, and K971588 Device Description: The Coalescent Surgical U-CLIPTMdevice is a self-closing clip for vascular anastomosis and tissue approxima… | 1997 |
What descends from it? (41)
See all 416 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031623 | Modification to Coalescent Surgical U-Clip and Accessories | 2003 | 32 |
| K033324 | Compression Anastomosis Clip (Cac) | 2004 | 7 |
| K062057 | U-Clip Device, Model NC65 | 2006 | 2 |
| K053252 | U-Clip Device, Models B140, B160 and B180 | 2005 | 1 |
| K081082 | U-Clip Uni-Fire, Model M65 | 2008 | 0 |
| K040821 | Coalescent Surgical U-Clip and Accessories | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2005 | Not classified | Z-0763-06 | Other | Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K031623 (Coalescent Surgical, 2003) has gone furthest, with 32 descendants of its own.
- 5 other devices also cite its predicate K023125.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 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?
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximatiodattachent and/or ligation 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.
https://510kreport.com/device/K024366 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024366: Coalescent Surgical U-Clip and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024366
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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