Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K230547 |
Device Name |
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter |
Applicant |
ConMed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Applicant Contact |
Ali AbuSaleh |
Correspondent |
ConMed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Correspondent Contact |
Ali AbuSaleh |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/28/2023 |
Decision Date | 04/27/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|