510(k) · Cleared
Recalled · 2010Modification to Coalescent 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 Jul 3, 2003 as substantially equivalent to K024366 (Coalescent Surgical, 2003) and 6 other predicates after a 41-day review. Its family tree reaches back 8 generations to 1993. 32 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 3, 2003
- Review
- 41 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 4
- Predicates
- 7
Its longest line of descent runs back 8 generations to K933887 (1993). 14 ancestors in all, the oldest K771412 (1977). 32 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 7 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 6 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 5 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 4 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 3 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 2 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 1 generation backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- This deviceK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003
- Descendant · cites it directly · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- Descendant · 2 generations on · 15 of its ownK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
- Descendant · 3 generations on · 10 of its ownK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016
- Descendant · 4 generations on · 9 of its ownK173031 AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017
- Descendant · 5 generations on · 8 of its ownK180010 AtriClip FLEX-VAtriCure, Inc. · 2018
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc. · 2010 · cites it directly18descendants
- K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012 · 2 generations on15descendants
- K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc. · 2016 · 3 generations on10descendants
- K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017 · 4 generations on9descendants
- K180010AtriClip FLEX-VAtriCure, Inc. · 2018 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −7 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −6 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −5 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −4 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −3 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −2 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −1 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| 0 (this device) | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | — |
| +1 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
| +2 | K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | 2012 | — |
| +3 | K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip | AtriCure, Inc. | 2016 | — |
| +4 | K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V Clip | AtriCure, Inc. | 2017 | — |
| +5 | K180010 | AtriClip FLEX-V | AtriCure, Inc. | 2018 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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 |
| 2026 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K024366 | Coalescent Surgical U-Clip and AccessoriesSummary page 1…cal U-CLIPTbland accessories is substantially equivalent in intended use, fabrication and design to the following predicate device: Coalescent Surgical U-CLIPTbl- K024366, KO23 125, KO2 1407, KO1 3664, KO123 17, K994160, and K971588 Device Description: The Coalescent Surgical U-CLIPT” devic… | 2003 |
| * | K023125 | Coalescent U-Clip- and AccessoriesSummary page 2…ng procedures. Comparison to Predicate Device(s): The Coalescent Surgical U-CLIPTMand accessories is substantially equivalent to the Coalescmt Surgical U-CLIP K024366, K023125, K021407, K013664, K012317, K994160 and K971.588 in terms of materials, use and application. Test Data: In vitro and in vivo da… | 2002 |
| * | K021407 | Coalescent Surgical U-Clip - or Other TBD and AccessoriesSummary page 2…ures. Comparison to Predicate Device(s): The Coalescent Surgical U-CLIPTMand accessories is substantially equivalent to the Coalescmt Surgical U-CLIP K024366, K023125, K021407, K013664, K012317, K994160 and K971.588 in terms of materials, use and application. Test Data: In vitro and in vivo data have c… | 2002 |
| * | K013664 | Coalescent Surgical U-ClipSummary page 2…mparison to Predicate Device(s): The Coalescent Surgical U-CLIPTMand accessories is substantially equivalent to the Coalescmt Surgical U-CLIP K024366, K023125, K021407, K013664, K012317, K994160 and K971.588 in terms of materials, use and application. Test Data: In vitro and in vivo data have confirmed… | 2002 |
| * | K012317 | Coalescent Surgical U-ClipSummary page 2…to Predicate Device(s): The Coalescent Surgical U-CLIPTMand accessories is substantially equivalent to the Coalescmt Surgical U-CLIP K024366, K023125, K021407, K013664, K012317, K994160 and K971.588 in terms of materials, use and application. Test Data: In vitro and in vivo data have confirmed that func… | 2001 |
| * | K994160 | Coalescent Surgical Sutured-ClipSummary page 1…in intended use, fabrication and design to the following predicate device: Coalescent Surgical U-CLIPTbl- K024366, KO23 125, KO2 1407, KO1 3664, KO123 17, K994160, and K971588 Device Description: The Coalescent Surgical U-CLIPT” device is a self-closing clip for vascular anastomosis and ti… | 2000 |
| * | K971588 | Evi Sutured-Clip ApplierSummary page 1…use, fabrication and design to the following predicate device: Coalescent Surgical U-CLIPTbl- K024366, KO23 125, KO2 1407, KO1 3664, KO123 17, K994160, and K971588 Device Description: The Coalescent Surgical U-CLIPT” device is a self-closing clip for vascular anastomosis and tissue approxim… | 1997 |
What descends from it? (32)
See all 325 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove… | 2010 | 18 |
| K040832 | C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050 | 2005 | 7 |
| K062057 | U-Clip Device, Model NC65 | 2006 | 2 |
| K053252 | U-Clip Device, Models B140, B160 and B180 | 2005 | 1 |
| 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 |
|---|---|---|---|---|
| Apr 2, 2010 | Not classified | Z-2030-2010 | Other | Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulling the clip through prosthetic… |
| Feb 25, 2008 | Not classified | Z-1609-2008 | Process control | Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW, that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain sufficient adhesive, which can allow the… |
| Feb 8, 2007 | Not classified | Z-0968-2007 | Other | Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device. |
| 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.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K093679 (AtriCure, Inc., 2010) has gone furthest, with 18 descendants of its own.
- 5 other devices also cite its predicate K024366.
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-CLIPTM 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/K031623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031623: Modification to 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/K031623
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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