K201313 is an FDA 510(k) clearance for the CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ). This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Aziyo Biologics, Inc. (Roswell, US). The FDA issued a Cleared decision on June 15, 2020, 28 days after receiving the submission on May 18, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K201313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2020 |
| Decision Date | June 15, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM - Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |