510(k) K201313
K201313 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 Enevlope (extra extra large) (SubQ)". The FDA issued a decision of Substantially Equivalent on June 15, 2020. 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
- June 15, 2020
- Date Received
- May 18, 2020
- 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