Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K221074 |
Device Name |
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device |
Applicant |
Stryker Corporation |
1941 Stryker Way |
Portage,
MI
49002
|
|
Applicant Contact |
Bruce Backlund |
Correspondent |
Stryker Corporation |
1941 Stryker Way |
Portage,
MI
49002
|
|
Correspondent Contact |
Bruce Backlund |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/12/2022 |
Decision Date | 09/16/2022 |
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
|