# K081082: U-Clip Uni-Fire, Model M65

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: May 7, 2008 after 21 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K933887 (1993). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062057: U-Clip Device, Model NC65, Medtronic Vascular (2006) Summary page 1.
- K024366: Coalescent Surgical U-Clip and Accessories, Coalescent Surgical (2003) Summary page 2.
- K060400: Cardioblate Surgical  Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation Device, Model 60831; Cardioblat, Medtronic, Inc. (2006) Summary page 2.
- K023125: Coalescent U-Clip- and Accessories, Coalescent Surgical (2002) Summary page 2.
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories, Coalescent Surgical (2002) Summary page 2.
- K013664: Coalescent Surgical U-Clip, Coalescent Surgical (2002) Summary page 2.
- K012317: Coalescent Surgical U-Clip, Coalescent Surgical (2001) Summary page 2.
- K994160: Coalescent Surgical Sutured-Clip, Coalescent Surgical (2000) Summary page 2.
- K971588: Evi Sutured-Clip Applier, Elective Vascular Intervention Inc. (Evi) (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K031623: Modification to Coalescent Surgical U-Clip and Accessories, Coalescent Surgical (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
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.

Source page: https://510kreport.com/device/K081082
Methodology: https://510kreport.com/methodology