510(k) · Cleared
ClearedU-Clip Uni-Fire, Model M65
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · FZP Clip, Implantable
Cleared on May 7, 2008 as substantially equivalent to K062057 (Medtronic Vascular, 2006) and 8 other predicates after a 21-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- May 7, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 10 generations to K933887 (1993). 56 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.
- Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 6 generations between
- 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 1 generation backK062057 U-Clip Device, Model NC65Medtronic Vascular · 2006
- This deviceK081082 U-Clip Uni-Fire, Model M65Medtronic, Inc. · 2008
Show all 10 generations
- Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 9 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 8 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 7 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 6 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 5 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 4 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 1 generation backK062057 U-Clip Device, Model NC65Medtronic Vascular · 2006
- This deviceK081082 U-Clip Uni-Fire, Model M65Medtronic, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −9 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −8 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −7 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −6 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −5 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −4 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −3 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −2 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
| −1 | K062057 | U-Clip Device, Model NC65 | Medtronic Vascular | 2006 | — |
| 0 (this device) | K081082 | U-Clip Uni-Fire, Model M65 | Medtronic, Inc. | 2008 | — |
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 |
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? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062057 | U-Clip Device, Model NC65Summary page 1…ification: Class II,21 CFR 878.4300 Product Code: FZP Predicate Device: Medtronic U-CLIP'", Model NC65 510(k) No. K062057, Reg. No. 878.4300; Product Code: FZP Device Intended Use: The U-CLIP device is intended for… | 2006 |
| Kept off the family tree | K031623 | FDA’s K031623 is Modification to Coalescent Surgical U-Clip and Accessories Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
| * | K024366 | Coalescent Surgical U-Clip and AccessoriesSummary page 2…e device is substantially equivalent to the U-CLIPTM Model NC65 device cleared in K062057 and other U- CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of material… | 2003 |
| * | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Summary page 2…is substantially equivalent to the U-CLIPTM Model NC65 device cleared in K062057 and other U- CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use an… | 2006 |
| * | K023125 | Coalescent U-Clip- and AccessoriesSummary page 2…ntially equivalent to the U-CLIPTM Model NC65 device cleared in K062057 and other U- CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and applica… | 2002 |
| * | K021407 | Coalescent Surgical U-Clip - or Other TBD and AccessoriesSummary page 2…U-CLIPTM Model NC65 device cleared in K062057 and other U- CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip is released… | 2002 |
| * | K013664 | Coalescent Surgical U-ClipSummary page 2…U-CLIPTM Model NC65 device cleared in K062057 and other U- CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip is released from… | 2002 |
| * | K012317 | Coalescent Surgical U-ClipSummary page 2…-CLIPTM Model NC65 device cleared in K062057 and other U- CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip is released from… | 2001 |
| * | K994160 | Coalescent Surgical Sutured-ClipSummary page 2…odel NC65 device cleared in K062057 and other U- CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip is released from… | 2000 |
| * | K971588 | Evi Sutured-Clip ApplierSummary page 2…ice cleared in K062057 and other U- CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip is released from the side of t… | 1997 |
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 15 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 56 ancestors have a recall of any class.
- 1 other device also cites its predicate K062057.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Uni-Fire 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/K081082 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081082: U-Clip Uni-Fire, Model M65.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081082
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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