SIBEL SA VASCULAR CLAMP— 510(k) K072834

Substantially Equivalent

Surgical Instruments Belgium SA

FDA 510(k) clearance K072834 for SIBEL SA VASCULAR CLAMP, Substantially Equivalent on 2008-01-09. Applicant: Surgical Instruments Belgium SA.

Clearance details

Applicant: Surgical Instruments Belgium SA
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2007-10-03
Decision date: 2008-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, NH, 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.