The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Everest Bipolar Cutting Forceps And Gyrus Bipolar Cutting Forceps.
| Device ID | K023492 |
| 510k Number | K023492 |
| Device Name: | EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, # 105 Minneapolis, MN 55311 -3602 |
| Contact | Frederick G Mades |
| Correspondent | Frederick G Mades GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, # 105 Minneapolis, MN 55311 -3602 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-18 |
| Decision Date | 2002-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925010628 | K023492 | 000 |
| 00821925011526 | K023492 | 000 |
| 00821925010345 | K023492 | 000 |
| 00821925010093 | K023492 | 000 |
| 00821925010703 | K023492 | 000 |
| 00821925010437 | K023492 | 000 |
| 00821925010413 | K023492 | 000 |
| 00821925010635 | K023492 | 000 |
| 00821925009981 | K023492 | 000 |
| 00821925009530 | K023492 | 000 |
| 00821925010352 | K023492 | 000 |
| 00821925009578 | K023492 | 000 |
| 00821925010277 | K023492 | 000 |
| 00821925010178 | K023492 | 000 |
| 00821925009943 | K023492 | 000 |
| 00821925010161 | K023492 | 000 |
| 00821925010567 | K023492 | 000 |