CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)— 510(k) K182255

Substantially Equivalent

Aziyo Biologics, Inc.

FDA 510(k) clearance K182255 for CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large), Substantially Equivalent on 2018-11-15. Applicant: Aziyo Biologics, Inc..

Clearance details

Applicant: Aziyo Biologics, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2018-08-20
Decision date: 2018-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
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.