Clearance Summary
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) received FDA 510(k) clearance under submission number K192616, sponsored by Aziyo Biologics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-10-21.
- Submission: K192616
- Applicant / Sponsor: Aziyo Biologics, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2019-10-21
Classification & Regulation
This clearance is catalogued under FDA product code FTM and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.