510(k) K070896 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENSEAL PTC TISSUE SEALING DEVICE
| Applicant | Surgrx, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Apr 24, 2007 |
| Received | Apr 2, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070896
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2010 | Ethicon Endo-Surgery Inc Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05 Terminated |
NLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.