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 | K172671 |
| 510k Number | K172671 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2017-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405003537 | K172671 | 000 |
| 10653405986089 | K172671 | 000 |
| 40653405064153 | K172671 | 000 |
| 20653405005534 | K172671 | 000 |
| 30653405001977 | K172671 | 000 |
| 30653405001960 | K172671 | 000 |
| 10653405986294 | K172671 | 000 |
| 10653405986287 | K172671 | 000 |
| 10653405001966 | K172671 | 000 |