The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode.
| Device ID | K031079 |
| 510k Number | K031079 |
| Device Name: | EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. Minneapolis, MN 55311 -3602 |
| Contact | Mercedes Bayani |
| Correspondent | Mercedes 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 | 2003-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925010901 | K031079 | 000 |
| 00821925010666 | K031079 | 000 |
| 00821925009707 | K031079 | 000 |