510(k) K161092 ยท OOD Surgical Film
GalaSHAPE 3D
| Applicant | Tepha, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Aug 23, 2016 |
| Received | Apr 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161092
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2016 | Tepha Incorporated GalaSHAPE 3D; product code SH3D03, a medium size oval
GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where wea Terminated |
OOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.