Device Classification Name |
instrument, ultrasonic surgical
|
510(k) Number |
K191555 |
Device Name |
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length |
Applicant |
Ethicon Endo-Surgery, LLC |
475 Calle C |
Guaynabo,
PR
00969
|
|
Applicant Contact |
Nathan Anderson |
Correspondent |
Ethicon Endo-Surgery, Inc. |
4545 Creek Road, ML39 |
Cincinnati,
OH
45242
|
|
Correspondent Contact |
Brian Godwin |
Classification Product Code |
|
Date Received | 06/12/2019 |
Decision Date | 02/28/2020 |
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
|
|
|