Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K163214 |
Device Name |
Unicare System, Unicare Manipulator |
Applicant |
ClearPath Surgical, Inc. |
1052 High Street |
Palo Alto,
CA
94301
|
|
Applicant Contact |
Puja Ohlhaver |
Correspondent |
ClearPath Surgical, Inc. |
1052 High Street |
Palo Alto,
CA
94301
|
|
Correspondent Contact |
Puja Ohlhaver |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 11/16/2016 |
Decision Date | 02/07/2017 |
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
|
|
|