# K040821: Coalescent Surgical U-Clip and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Coalescent Surgical
- Decided: Apr 23, 2004 after 24 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: 9 generations back to K933887 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031623: Modification to Coalescent Surgical U-Clip and Accessories, Coalescent Surgical (2003) Summary page 1.
- K024366: Coalescent Surgical U-Clip and Accessories, Coalescent Surgical (2003) Summary page 1.
- K023125: Coalescent U-Clip- and Accessories, Coalescent Surgical (2002) Summary page 1.
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories, Coalescent Surgical (2002) Summary page 1.
- K013664: Coalescent Surgical U-Clip, Coalescent Surgical (2002) Summary page 1.
- K012317: Coalescent Surgical U-Clip, Coalescent Surgical (2001) Summary page 1.
- 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.

## Indications for use
The Coalescent Surgical PG-CLIPTM and accessories are intended for endoscopic and non-endoscopic peripheral vascular and general surgical soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in peripheral vascular blood vessels, grafts and other tubular structures. The PG-CLIP is not intended for use in cardiac and/or thoracic procedures; including, but not limited to intra-cardiac and coronary artery bypass grafting (CABG) procedures.

Source page: https://510kreport.com/device/K040821
Methodology: https://510kreport.com/methodology