510(k) K162053 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PhotonBlade
| Applicant | Invuity, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Sep 15, 2016 |
| Received | Jul 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2017 | Invuity, Inc. INVUITY(R) PhotonBlade(TM), REF PB1 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.