GEM Biover Microvascular Clamps— 510(k) K221843

Substantially Equivalent

Synovis Micro Companies Alliance, Inc.

FDA 510(k) clearance K221843 for GEM Biover Microvascular Clamps, Substantially Equivalent on 2022-09-14. Applicant: Synovis Micro Companies Alliance, Inc..

Clearance details

Applicant: Synovis Micro Companies Alliance, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2022-06-24
Decision date: 2022-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Birmingham, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.