Biodesign Enterocutaneous Fistula Plug— 510(k) K150668

Substantially Equivalent

Cook Biotech Incorprated

FDA 510(k) clearance K150668 for Biodesign Enterocutaneous Fistula Plug, Substantially Equivalent on 2015-12-09. Applicant: Cook Biotech Incorprated.

Clearance details

Applicant: Cook Biotech Incorprated
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2015-03-16
Decision date: 2015-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.