# K023125: Coalescent U-Clip- and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Coalescent Surgical
- Decided: Dec 18, 2002 after 90 days
- Product code: NJU (Suture, Nonabsorbable, Nitinol)
- Device class: 2
- Regulation: 21 CFR 878.4495
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933887 (1993). 12 ancestors in all.
42 later devices descend from it; 6 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories, Coalescent Surgical (2002)
- K013664: Coalescent Surgical U-Clip, Coalescent Surgical (2002)
- K012317: Coalescent Surgical U-Clip, Coalescent Surgical (2001)
- 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.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K153500: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip (2016), 10 descendants of its own

## Indications for use
The Coalescent Surgical U-CLIPTM and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.

Source page: https://510kreport.com/device/K023125
Methodology: https://510kreport.com/methodology