CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)— 510(k) K192616

Substantially Equivalent

Aziyo Biologics, Inc.

FDA 510(k) clearance K192616 for CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ), Substantially Equivalent on 2019-10-21. Applicant: Aziyo Biologics, Inc..

Clearance details

Applicant: Aziyo Biologics, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2019-09-23
Decision date: 2019-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, 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.