Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K190744 |
Device Name |
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) |
Applicant |
Olympus Winter & Ibe GmbH |
Kuehnstr. 61 |
Hamburg,
DE
22045
|
|
Applicant Contact |
Jan-Oliver Upmeier |
Correspondent |
Olympus Corporation of the Americas |
3500 Corporate Parkway |
Center Valley,
PA
18034 -061
|
|
Correspondent Contact |
Sheri L Musgnung |
Regulation Number | 884.1720
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/22/2019 |
Decision Date | 08/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|