TUTOPATCH— 510(k) K991296

Substantially Equivalent

Tutogen Medical U.S., Inc.

FDA 510(k) clearance K991296 for TUTOPATCH, Substantially Equivalent on 2000-10-06. Applicant: Tutogen Medical U.S., Inc..

Clearance details

Applicant: Tutogen Medical U.S., Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 1999-04-15
Decision date: 2000-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, 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.