510(k) · Cleared
ClearedCoalescent Surgical U-Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coalescent Surgical · FZP Clip, Implantable
Cleared on Aug 31, 2001 as substantially equivalent to K994160 (Coalescent Surgical, 2000) after a 39-day review. Its family tree reaches back 3 generations to 1993. 52 later devices descend from it.
- Decided
- Aug 31, 2001
- Review
- 39 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933887 (1993). 5 ancestors in all, the oldest K771412 (1977). 52 later devices descend from it, 10 citing it directly.
- Root · 3 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 2 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 1 generation backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- This deviceK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- Descendant · cites it directly · 44 of its ownK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- Descendant · 2 generations on · 43 of its ownK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- Descendant · cites it directly · 42 of its ownK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- Descendant · cites it directly · 41 of its ownK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- Descendant · cites it directly · 32 of its ownK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002 · cites it directly44descendants
- K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002 · 2 generations on43descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −2 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −1 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| 0 (this device) | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| +1 | 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 | — |
| +1 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| +1 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994160 | Coalescent Surgical Sutured-ClipSummary page 1…nt Surgical U-Clip™ is substantially equivalent in intended use and method of operation to the following predicate devices: e Coalescent Surgical Sutured-Clip™ - 510(k) K994160 Device Description: The Coalescent Surgical U-Clip™ is a single self-closing clip for vascular anastomosis and tissue approxima… | 2000 |
What descends from it? (52)
See all 5210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013664 | Coalescent Surgical U-Clip | 2002 | 44 |
| K023125 | Coalescent U-Clip- and Accessories | 2002 | 42 |
| K024366 | Coalescent Surgical U-Clip and Accessories | 2003 | 41 |
| K031623 | Modification to Coalescent Surgical U-Clip and Accessories | 2003 | 32 |
| K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and… | 2010 | 5 |
| 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 |
| K032896 | Anson Refix Vascular and Tissue Clip, Models GF-04-01 and GF-04-02 | 2004 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K013664 (Coalescent Surgical, 2002) has gone furthest, with 44 descendants of its own.
- 10 other devices also cite its predicate K994160.
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 use in
tissue and prosthetic material approximation and the creation of anastomoses in blood
vessels, grafts and other tubular structures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012317 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012317: Coalescent Surgical U-Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012317
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026