# K012317: Coalescent Surgical U-Clip

- Pathway: 510(k) (Traditional)
- Applicant: Coalescent Surgical
- Decided: Aug 31, 2001 after 39 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: 3 generations back to K933887 (1993). 5 ancestors in all.
52 later devices descend from it; 10 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994160: Coalescent Surgical Sutured-Clip, Coalescent Surgical (2000) Summary page 1.

## Most influential descendants
- K013664: Coalescent Surgical U-Clip (2002), 44 descendants of its own
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories (2002), 43 descendants of its own
- K023125: Coalescent U-Clip- and Accessories (2002), 42 descendants of its own
- K024366: Coalescent Surgical U-Clip and Accessories (2003), 41 descendants of its own
- K031623: Modification to Coalescent Surgical U-Clip and Accessories (2003), 32 descendants of its own

## Indications for use
The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures.

Source page: https://510kreport.com/device/K012317
Methodology: https://510kreport.com/methodology