FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
ManipulatOR PRO, ManipulatOR
K Number: K150519
·
Decision Aug 19, 2015
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
4
Review Days
170
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ManipulatOR PRO, ManipulatOR
- K Number
- K150519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gynetech Pty. , Ltd.
- Date Received
- March 2, 2015
- Decision Date
- August 19, 2015
- Product Code
- LKF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKF), ordered by most recent decision date.
FemVue® Controlled Saline-Air Device (FSA-300)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RELIEEV HSG Catheter (HSG7FA1)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FemVue MINI Saline-Air Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FemChec Controlled Saline-Air Device (FCD-250)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Rejoni Intrauterine Catheter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology