Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K221671 |
Device Name |
CellFX® System |
Applicant |
Pulse Biosciences, Inc. |
3957 Point Eden Way |
Hayward,
CA
94545
|
|
Applicant Contact |
Punam Gollamudi |
Correspondent |
Pulse Biosciences, Inc. |
3957 Point Eden Way |
Hayward,
CA
94545
|
|
Correspondent Contact |
Punam Gollamudi |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/09/2022 |
Decision Date | 08/01/2022 |
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
|
|
|