Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K170660 |
Device Name |
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula |
Applicant |
CooperSurgical, Inc. |
95 Corporate Drive |
Trumbull,
CT
06611
|
|
Applicant Contact |
Roaida Johnson |
Correspondent |
CooperSurgical, Inc. |
95 Corporate Drive |
Trumbull,
CT
06611
|
|
Correspondent Contact |
Roaida Johnson |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/03/2017 |
Decision Date | 07/13/2017 |
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
|
|
|