K192616 is an FDA 510(k) clearance for the CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (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 October 21, 2019, 28 days after receiving the submission on September 23, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K192616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2019 |
| Decision Date | October 21, 2019 |
| 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 |