The following data is part of a premarket notification filed by Gyrus Medical Ltd. with the FDA for Gyrus G3 System (generator, Assessories, Somnoplasty Electrodes And Plasmacision Electrodes).
| Device ID | K041285 |
| 510k Number | K041285 |
| Device Name: | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL LTD. FORTRAN RD., ST. MELLONS Cardiff, GB Cf3 0lt |
| Contact | Andrew Dzimitrowicz |
| Correspondent | Andrew Dzimitrowicz GYRUS MEDICAL LTD. FORTRAN RD., ST. MELLONS Cardiff, GB Cf3 0lt |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-13 |
| Decision Date | 2004-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925041370 | K041285 | 000 |
| 00821925026735 | K041285 | 000 |
| 00821925026728 | K041285 | 000 |
| 00821925026711 | K041285 | 000 |
| 00821925026704 | K041285 | 000 |
| 00821925026698 | K041285 | 000 |
| 00821925010864 | K041285 | 000 |