The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Gyrus Plasmakinetic Superpulse System (generator, Accessories).
| Device ID | K031085 |
| 510k Number | K031085 |
| Device Name: | GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. SUITE 105 Maple Grove, MN 55311 -3602 |
| Contact | Mercedes Bayani |
| Correspondent | Mercedes Bayani GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. SUITE 105 Maple Grove, MN 55311 -3602 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-04 |
| Decision Date | 2003-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925039599 | K031085 | 000 |
| 00821925009202 | K031085 | 000 |
| 00821925008991 | K031085 | 000 |
| 00821925011342 | K031085 | 000 |
| 00821925011335 | K031085 | 000 |
| 00821925010802 | K031085 | 000 |
| 00821925009820 | K031085 | 000 |
| 00821925009271 | K031085 | 000 |