510(k) Report

510(k) · Cleared

Cleared

U-Clip Device

K062821510(k) TraditionalCleared Dec 19, 200690-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Neurosurgery · FZP Clip, Implantable

Cleared on Dec 19, 2006 as substantially equivalent to K062057 (Medtronic Vascular, 2006) and 4 other predicates after a 90-day review. Its family tree reaches back 10 generations to 1993.

Decided
Dec 19, 2006
Review
90 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K933887 (1993). 59 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 2 other ancestors2000: 4 other ancestors1998: 5 other ancestors2001: 6 other ancestors1997: 10 other ancestors1993: 1 other ancestor2003: 1 other ancestor1995: 6 other ancestors1977: 1 other ancestor2002: 2 other ancestors1992: 2 other ancestors1999: 3 other ancestors1994: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestor1996: 2 other ancestors1991: 1 other ancestorK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000K012317 · Coalescent Surgical U-Clip · Coalescent Surgical · 2001K013664 · Coalescent Surgical U-Clip · Coalescent Surgical · 2002K021407 · Coalescent Surgical U-Clip - or Other TBD and Accessories · Coalescent Surgical · 2002×2: 2 generations cleared close together, K023125 (2002), K024366 (2003) K031623 · Modification to Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK053252 · U-Clip Device, Models B140, B160 and B180 · Medtronic Vascular · 20051975198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 4 other ancestors4 generations back: 2 other ancestors5 generations back: 6 other ancestors6 generations back: 15 other ancestors7 generations back: 8 other ancestors8 generations back: 7 other ancestors K053252 · U-Clip Device, Models B140, B160 and B180 · Medtronic Vascular · 2005K031623 · Modification to Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK024366 · Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK023125 · Coalescent U-Clip- and Accessories · Coalescent Surgical · 2002K021407 · Coalescent Surgical U-Clip - or Other TBD and Accessories · Coalescent Surgical · 2002K013664 · Coalescent Surgical U-Clip · Coalescent Surgical · 2002K012317 · Coalescent Surgical U-Clip · Coalescent Surgical · 2001K994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993−10−50
  1. Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 6 generations between
  3. 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  4. 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  5. 1 generation backK053252 U-Clip Device, Models B140, B160 and B180Medtronic Vascular · 2005
  6. This deviceK062821 U-Clip DeviceMedtronic Neurosurgery · 2006
Show all 10 generations
  1. Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 9 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
  3. 8 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  4. 7 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  5. 6 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  6. 5 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  7. 4 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  8. 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  9. 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  10. 1 generation backK053252 U-Clip Device, Models B140, B160 and B180Medtronic Vascular · 2005
  11. This deviceK062821 U-Clip DeviceMedtronic Neurosurgery · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K933887Implantable ClipUnited States Surgical, A Division of Tyco Healthc1993—
−9K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc19967
−8K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
−7K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
−6K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
−5K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
−4K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical2002—
−3K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20031
−2K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20034
−1K053252U-Clip Device, Models B140, B160 and B180Medtronic Vascular2005—
0 (this device)K062821U-Clip DeviceMedtronic Neurosurgery2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
198110
198810
199110
199220
199310
199410
199560
199620
1997100
199850
199930
200040
200160
200220
200310
200620
FIG. 1 — Lineage of K062821, 1993–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K062057U-Clip Device, Model NC65
Summary page 1
…n. Predicate Device Identification: The U-CLIPTM Device is substantially equivalent to the following predicate device: * U-CLIPTM Device - K062057, K053252, K01 3664 The predicate devices intended for tissue approximation have been cleared for neurological applic…
Medtronic Vascular2006—
*K053252U-Clip Device, Models B140, B160 and B180
Summary page 1
…Predicate Device Identification: The U-CLIPTM Device is substantially equivalent to the following predicate device: * U-CLIPTM Device - K062057, K053252, K01 3664 The predicate devices intended for tissue approximation have been cleared for neurological applications in…
Medtronic Vascular2005—
*K013664Coalescent Surgical U-Clip
Summary page 1
…te Device Identification: The U-CLIPTM Device is substantially equivalent to the following predicate device: * U-CLIPTM Device - K062057, K053252, K01 3664 The predicate devices intended for tissue approximation have been cleared for neurological applications include:…
Coalescent Surgical2002—
*K001625Pronova Nonabsorbable Suture, Usp
Summary page 1
…tended for tissue approximation have been cleared for neurological applications include: * Ethicon, Polypropylene, PRONOVA Nonasbsorbable Suture - K001625 * Surgilon/Polyamide Nonabsorbable Surgical Suture - K981582…
ETHICON, Inc.2000—
*K981582Surgilon, Dermalon, & Ophthalon
Summary page 1
…ications include: * Ethicon, Polypropylene, PRONOVA Nonasbsorbable Suture - K001625 * Surgilon/Polyamide Nonabsorbable Surgical Suture - K981582 K062821 Predicate Device…
Davis & Geck, Inc.19989

Also cleared against K062057: 1 other device →

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 13 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
  • 7 of the 59 ancestors have a recall of any class.
  • 1 other device also cites its predicate K062057.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZP

5in 2025

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
2007high 6 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FZP

1,902in 2025

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—

What is it indicated for?

The U-CLIPTM Device is intended for endoscopic and non-endoscopic dura mater and

prosthetic material approximation/attachment and/or ligation in neurosurgical

procedures.

Indications for use as stated in the FDA summary.

Also cleared against K062057

1 other device cites the same predicate.

  • K081082U-Clip Uni-Fire, Model M65Medtronic, Inc. · 2008

More from Medtronic Neurosurgery

28 FDA decisions under this applicant name. See the company

  • K243676Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2025
  • K242034Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2024
  • K212641StrataMR II Valves and ShuntsMedtronic Neurosurgery · 2021
  • K181622StrataMR guider toolMedtronic Neurosurgery · 2018
  • K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 20161 recall

Recent decisions in FZP

The FZP category page

  • K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

https://510kreport.com/device/K062821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062821: U-Clip Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062821

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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