Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K212643 |
Device Name |
POWERSEAL Curved Jaw Sealer and Divider, Double Action |
Applicant |
Olympus Surgical Technologies America |
9600 Louisiana Blvd North |
Brooklyn Park,
MN
55455
|
|
Applicant Contact |
Christina Flores |
Correspondent |
Olympus Surgical Technologies America |
9600 Louisiana Blvd North |
Brooklyn Park,
MN
55455
|
|
Correspondent Contact |
Christina Flores |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/20/2021 |
Decision Date | 09/27/2021 |
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
|
Recalls |
CDRH Recalls
|