Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K112033 |
Device Name |
ENSEAL G2 TISSUS SEALERS |
Applicant |
ETHICON ENDO-SUGERY, LLC |
4545 CREEK RD. |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
DONOVAN MAY |
Correspondent |
ETHICON ENDO-SUGERY, LLC |
4545 CREEK RD. |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
DONOVAN MAY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/15/2011 |
Decision Date | 11/08/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|