FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
ColpoWave Colpotomizer and CerviGrip Uterine Manipulator
K Number: K161065
·
Decision Oct 27, 2016
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
17
Applicant Total
1
Review Days
195
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Basic Information
- Device Name
- ColpoWave Colpotomizer and CerviGrip Uterine Manipulator
- K Number
- K161065
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1640
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgitools Pty , Ltd.
- Date Received
- April 15, 2016
- Decision Date
- October 27, 2016
- Product Code
- HEW
- 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 |
|---|---|---|---|
| HEW | Culdoscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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