The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Helixar Electrosurgical Generator With Argon Beam Coagulation, Helixar Mobile Pedestal.
| Device ID | K152860 |
| 510k Number | K152860 |
| Device Name: | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Contact | Lisa Anderson |
| Correspondent | Lisa Anderson CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2015-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405001970 | K152860 | 000 |
| 20653405001994 | K152860 | 000 |
| 30653405000758 | K152860 | 000 |
| 10653405005537 | K152860 | 000 |