DeviceClearance

PORCINE SURGICAL MESH; DERMAL MATRIX— 510(k) K081272

Substantially Equivalent

Brennen Medical, LLC

FDA 510(k) clearance K081272 for PORCINE SURGICAL MESH; DERMAL MATRIX, Substantially Equivalent on 2008-07-31. Applicant: Brennen Medical, LLC.

Clearance details

Applicant
Brennen Medical, LLC
Product code
Code FTM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

Source: openFDA MAUDE database, through . 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.