# K221843: GEM Biover Microvascular Clamps

- Pathway: 510(k) (Special)
- Applicant: Synovis Micro Companies Alliance, Inc.
- Decided: Sep 14, 2022 after 82 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011208 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011208: Biover, Biover AG (2002) Summary page 4.

## Indications for use
GEMM BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.

Source page: https://510kreport.com/device/K221843
Methodology: https://510kreport.com/methodology