AFB (ABSORBABLE FOAM BUTTRESS)— 510(k) K014183

Substantially Equivalent

J&J Corporate Biomaterials Center

FDA 510(k) clearance K014183 for AFB (ABSORBABLE FOAM BUTTRESS), Substantially Equivalent on 2002-06-12. Applicant: J&J Corporate Biomaterials Center.

Clearance details

Applicant: J&J Corporate Biomaterials Center
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2001-12-20
Decision date: 2002-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sommerville, NJ, 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.