510(k) · Cleared
ClearedU-Clip Device, Models B140, B160 and B180
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · FZP Clip, Implantable
Cleared on Dec 16, 2005 as substantially equivalent to K031623 (Coalescent Surgical, 2003) and 7 other predicates after a 25-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Dec 16, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K933887 (1993). 15 ancestors in all, the oldest K771412 (1977). 1 later device descends from it, 1 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 deviceK053252 U-Clip Device, Models B140, B160 and B180Medtronic Vascular · 2005
- 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 deviceK053252 U-Clip Device, Models B140, B160 and B180Medtronic Vascular · 2005
Most influential descendants
Showing 1 of 1 · See all- K062821U-Clip DeviceMedtronic Neurosurgery · 2006 · cites it directly0descendants
View 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) | K053252 | U-Clip Device, Models B140, B160 and B180 | Medtronic Vascular | 2005 | — |
| +1 | K062821 | U-Clip Device | Medtronic Neurosurgery | 2006 | — |
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 |
|---|---|---|
| 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? (8)
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 2…gation. Comparison to Predicate Device(s): The Medtronic U-CLIP devices are substantially equivalent to the Coalescent Surgical U-CLIP'T " K031623. K024366, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of… | 2003 |
| * | K024366 | Coalescent Surgical U-Clip and AccessoriesSummary page 1…ss II, 21 CER 878.4300 Product Code: FZP Predicate Device: Coalescent Surgical U-CLI PT M 5 10(k) No. K024366, Reg. No. 878.4300; Product Code: FZP Device Intended Use: The Surgical U-CLIP'TM is intended… | 2003 |
| * | K023125 | Coalescent U-Clip- and AccessoriesSummary page 2…: The Medtronic U-CLIP devices are substantially equivalent to the Coalescent Surgical U-CLIP'T " K031623. K024366, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new… | 2002 |
| * | K021407 | Coalescent Surgical U-Clip - or Other TBD and AccessoriesSummary page 2…Medtronic U-CLIP devices are substantially equivalent to the Coalescent Surgical U-CLIP'T " K031623. K024366, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new… | 2002 |
| * | K013664 | Coalescent Surgical U-ClipSummary page 2…c U-CLIP devices are substantially equivalent to the Coalescent Surgical U-CLIP'T " K031623. K024366, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new… | 2002 |
| * | K012317 | Coalescent Surgical U-ClipSummary page 2…devices are substantially equivalent to the Coalescent Surgical U-CLIP'T " K031623. K024366, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new sizes… | 2001 |
| * | K994160 | Coalescent Surgical Sutured-ClipSummary page 2…re substantially equivalent to the Coalescent Surgical U-CLIP'T " K031623. K024366, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new sizes are a li… | 2000 |
| * | K971588 | Evi Sutured-Clip ApplierSummary page 2…the Coalescent Surgical U-CLIP'T " K031623. K024366, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new sizes are a line extension of larger sized clips.… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062821 | U-Clip Device | 2006 | 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 12 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K062821 (Medtronic Neurosurgery, 2006) 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053252 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053252: U-Clip Device, Models B140, B160 and B180.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053252
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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