510(k) K192616
K192616 is an FDA 510(k) premarket notification submitted by Aziyo Biologics, Inc. for the device "CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)". The FDA issued a decision of Substantially Equivalent on October 21, 2019. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Aziyo Biologics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2019
- Date Received
- September 23, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type