4DDOME— 510(k) K070918

Substantially Equivalent

Cousin Biotech

FDA 510(k) clearance K070918 for 4DDOME, Substantially Equivalent on 2007-08-22. Applicant: Cousin Biotech.

Clearance details

Applicant: Cousin Biotech
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2007-04-02
Decision date: 2007-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

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.