# K031623: Modification to Coalescent Surgical U-Clip and Accessories

- Pathway: 510(k) (Special)
- Applicant: Coalescent Surgical
- Decided: Jul 3, 2003 after 41 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933887 (1993). 14 ancestors in all.
32 later devices descend from it; 5 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024366: Coalescent Surgical U-Clip and Accessories, Coalescent Surgical (2003) Summary page 1.
- 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 1.
- K971588: Evi Sutured-Clip Applier, Elective Vascular Intervention Inc. (Evi) (1997) Summary page 1.

## Most influential descendants
- K093679: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide  Model Various LAA0 (2010), 18 descendants of its own
- K122276: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip (2012), 15 descendants of its own
- K153500: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip (2016), 10 descendants of its own
- K173031: AtriClip LAA Exclusion System with Preloaded PRO·V Clip (2017), 9 descendants of its own
- K180010: AtriClip FLEX-V (2018), 8 descendants of its own

## Recalls of this device
- Apr 2, 2010 · Not classified · Z-2030-2010: Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulli
- Feb 25, 2008 · Not classified · Z-1609-2008: Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW, that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain suffic
- Feb 8, 2007 · Not classified · Z-0968-2007: Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose t
- Sep 1, 2005 · Not classified · Z-0763-06: Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips.

## Indications for use
The Coalescent Surgical U-CLIPTM is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximatiodattachent and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

Source page: https://510kreport.com/device/K031623
Methodology: https://510kreport.com/methodology