CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)— 510(k) K173242

Substantially Equivalent

Aziyo Biologics, Inc.

FDA 510(k) clearance K173242 for CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), Substantially Equivalent on 2017-10-25. Applicant: Aziyo Biologics, Inc..

Clearance details

Applicant: Aziyo Biologics, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2017-10-06
Decision date: 2017-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, 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.