510(k) K182255 ยท FTM Mesh, Surgical
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
| Applicant | Aziyo Biologics, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Nov 15, 2018 |
| Received | Aug 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | AZIYO BIOLOGICS CanGaroo Envelopes labeled as the following:
1. CanGaroo Envelope (Large) (single pack);
2. CanGaroo Envelope (Medium) (single pack);
3. CanGaroo Envelope (Extra Large) (single pack);
4. C Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.