510(k) · Cleared
ClearedU-Clip Device, Model NC65
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · FZP Clip, Implantable
Cleared on Aug 2, 2006 as substantially equivalent to K031623 (Coalescent Surgical, 2003) and 8 other predicates after a 13-day review. Its family tree reaches back 9 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 2, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 9 generations to K933887 (1993). 55 ancestors in all, the oldest K771412 (1977). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 5 generations between
- 3 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 2 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 1 generation backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- This deviceK062057 U-Clip Device, Model NC65Medtronic Vascular · 2006
- Descendant · cites it directly · 0 of its ownK081082 U-Clip Uni-Fire, Model M65Medtronic, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK062821 U-Clip DeviceMedtronic Neurosurgery · 2006
Show all 9 generations
- Root · 9 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 8 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 7 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 6 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 5 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 4 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 3 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 2 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 1 generation backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- This deviceK062057 U-Clip Device, Model NC65Medtronic Vascular · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −8 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −7 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −6 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −5 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −4 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −3 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −2 | 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 |
| 0 (this device) | K062057 | U-Clip Device, Model NC65 | Medtronic Vascular | 2006 | — |
| +1 | K081082 | U-Clip Uni-Fire, Model M65 | Medtronic, Inc. | 2008 | — |
| +1 | K062821 | U-Clip Device | Medtronic Neurosurgery | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 10 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 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? (9)
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 |
|---|---|---|---|
| * | K031623 | Modification to Coalescent Surgical U-Clip and AccessoriesSummary page 1…fication: Class II,21 CFR 878.4300 Product Code: FZP Predicate Device: Coalescent Surgical U-CLIP'm 510(k) No. K031623, Reg. No. 878.4300; Product Code: FZP Device Intended Use: The Surgical U-CLIPTM is intended for… | 2003 |
| * | K024366 | Coalescent Surgical U-Clip and AccessoriesSummary page 2…quivalent to the U-CLIP TM devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materi… | 2003 |
| * | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Summary page 2…to the U-CLIP TM devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use… | 2006 |
| * | K023125 | Coalescent U-Clip- and AccessoriesSummary page 2…-CLIP TM devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and appli… | 2002 |
| * | K021407 | Coalescent Surgical U-Clip - or Other TBD and AccessoriesSummary page 2…TM devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip utilizes a… | 2002 |
| * | K013664 | Coalescent Surgical U-ClipSummary page 2…TM devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip utilizes a… | 2002 |
| * | K012317 | Coalescent Surgical U-ClipSummary page 2…TM devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip utilizes a… | 2001 |
| * | K994160 | Coalescent Surgical Sutured-ClipSummary page 2…TM devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip utilizes a diff… | 2000 |
| * | K971588 | Evi Sutured-Clip ApplierSummary page 2…TM devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip utilizes a different way of… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 6 of the 55 ancestors have a recall of any class.
- Of its descendants, K081082 (Medtronic, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K031623.
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 U-CLIP TM Device is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis 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/K062057 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062057: U-Clip Device, Model NC65.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062057
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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