CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
FDA 510(k) clearance K192616 · decided 2019-10-21
Clearance details
- K-number
- K192616
- Device name
- CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
- Applicant
- Aziyo Biologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-23
- Decision date
- 2019-10-21
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.