Device Classification Name |
instrument, ultrasonic surgical
|
510(k) Number |
K121550 |
Device Name |
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY |
Applicant |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
MARCIA ARETZ |
Correspondent |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
MARCIA ARETZ |
Classification Product Code |
|
Date Received | 05/25/2012 |
Decision Date | 08/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|