Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K221557 |
Device Name |
Visera Hysterovideoscope Olympus HYF Type V |
Applicant |
Olympus Medical Systems Corporation |
2951 Ishikawa-cho, Hachioji-shi |
Tokyo,
JP
|
|
Applicant Contact |
Toshio Nakamura |
Correspondent |
Olympus Corporation of the Americas |
800 West Park Drive |
Westborough,
MA
01581
|
|
Correspondent Contact |
Gary Brennan |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 05/31/2022 |
Decision Date | 09/02/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|