Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K160554 |
Device Name |
Enseal X1 Large Jaw Tissue Sealer |
Applicant |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK RD |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
DAVID LOCKE |
Correspondent |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK RD |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
DAVID LOCKE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/29/2016 |
Decision Date | 09/09/2016 |
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
|