The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Edge Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension.
| Device ID | K153499 |
| 510k Number | K153499 |
| Device Name: | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
| Contact | Dionne Sanders |
| Correspondent | Dionne Sanders 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 | 2015-12-07 |
| Decision Date | 2015-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405986321 | K153499 | 000 |
| 20653405986314 | K153499 | 000 |
| 40653405081976 | K153499 | 000 |