The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Gyrus Ent Cogent 2/g2 System (generator,accessories Somnoplasty Electrodes And Plasmacision Electrodes).
| Device ID | K021777 |
| 510k Number | K021777 |
| Device Name: | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Jeffrey W Cobb |
| Correspondent | Jeffrey W Cobb GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-30 |
| Decision Date | 2002-08-26 |
| Summary: | summary |