The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420.
| Device ID | K020778 |
| 510k Number | K020778 |
| Device Name: | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Jeffery W Cobb |
| Correspondent | Jeffery 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 | 2002-03-11 |
| Decision Date | 2002-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925009424 | K020778 | 000 |