510(k) K091107 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
| Applicant | Hemostatix Medical Technologies, LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, May 1, 2009 |
| Received | Apr 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091107
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2010 | Hemostatix Medical Technologies LLC HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF 7013-5050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD Terminated |
GEI | None listed |
| Sep 28, 2010 | Hemostatix Medical Technologies LLC MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.