# K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Coalescent Surgical
- Decided: Jul 3, 2002 after 61 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: 5 generations back to K933887 (1993). 10 ancestors in all.
43 later devices descend from it; 7 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013664: Coalescent Surgical U-Clip, Coalescent Surgical (2002)

## Most influential descendants
- 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
- 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

## Indications for use
The Coalescent Surgical U-CLIPTM is intended for endoscopic and non-endoscopic tissue and prosthetic material approximatiodattachent 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/K021407
Methodology: https://510kreport.com/methodology