CABS'AIR— 510(k) K072962

Substantially Equivalent

Cousin Biotech Sas

FDA 510(k) clearance K072962 for CABS'AIR, Substantially Equivalent on 2008-06-26. Applicant: Cousin Biotech Sas.

Clearance details

Applicant: Cousin Biotech Sas
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2007-10-19
Decision date: 2008-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wervicq-Sud, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.