PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH— 510(k) K043388

Substantially Equivalent

Pegasus Biologics, Inc.

FDA 510(k) clearance K043388 for PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH, Substantially Equivalent on 2005-08-05. Applicant: Pegasus Biologics, Inc..

Clearance details

Applicant: Pegasus Biologics, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2004-12-09
Decision date: 2005-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.