CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)— 510(k) K201313

Name: FDA 510(k) clearance K201313
Creator: U.S. Food and Drug Administration
Published: 2020-06-15

Substantially Equivalent

Aziyo Biologics, Inc.

FDA 510(k) clearance K201313 for CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ), Substantially Equivalent on 2020-06-15. Applicant: Aziyo Biologics, Inc.. Device class: 2.

Clearance details

Applicant: Aziyo Biologics, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2020-05-18
Decision date: 2020-06-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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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.