The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro & Molly Forceps.
| Device ID | K031078 |
| 510k Number | K031078 |
| Device Name: | EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. Minneapolis, MN 55311 -3602 |
| Contact | Mercedes P Bayani |
| Correspondent | Mercedes P Bayani GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. 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 | 2003-04-04 |
| Decision Date | 2003-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925009905 | K031078 | 000 |
| 00821925010307 | K031078 | 000 |
| 00821925009325 | K031078 | 000 |
| 00821925010291 | K031078 | 000 |
| 00821925009882 | K031078 | 000 |
| 00821925009844 | K031078 | 000 |
| 00821925010895 | K031078 | 000 |
| 00821925010918 | K031078 | 000 |
| 00821925009790 | K031078 | 000 |
| 00821925009639 | K031078 | 000 |
| 00821925010956 | K031078 | 000 |
| 00821925009769 | K031078 | 000 |
| 00821925010253 | K031078 | 000 |
| 00821925009370 | K031078 | 000 |
| 00821925010369 | K031078 | 000 |