Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) 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 |
Applicant |
ConMed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Applicant Contact |
Dionne Sanders |
Correspondent |
ConMed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Correspondent Contact |
Dionne Sanders |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/07/2015 |
Decision Date | 12/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|