# K242541: Gem Zipclip

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Micro Companies Alliance A Subsidiary of Baxter Int
- Decided: Jan 15, 2025 after 142 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 K771021 (1977). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981645: Titanium Hemostatic Clip, Vitalitec Int'L., Inc. (1998) Summary page 5.

## Indications for use
ZIPCLIP is indicated for use in surgical procedures to occlude blood vessels.

Source page: https://510kreport.com/device/K242541
Methodology: https://510kreport.com/methodology