510(k) K963088 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SHEATH, ELECTROSURGICAL PENCIL
| Applicant | Aspen Laboratories, Inc., Centennial CO, US |
| Decision | Substantially Equivalent, Sep 13, 1996 |
| Received | Aug 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. T Terminated |
GEI | None listed |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . Terminated |
GEI | None listed |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, Terminated |
GEI | None listed |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. T Terminated |
GEI | None listed |
| Feb 28, 2017 | ConMed Corporation HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 200 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.