FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
DUMI ManipulatOR
K Number: K212505
·
Decision Jan 10, 2022
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
2
Review Days
154
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Basic Information
- Device Name
- DUMI ManipulatOR
- K Number
- K212505
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The O R Company Pty, Ltd.
- Date Received
- August 9, 2021
- Decision Date
- January 10, 2022
- 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 |
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Other Clearances by The O R Company Pty, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220202 | Uterine ElevatOR PRO with OccludOR Balloon | Mar 31, 2022 | Substantially Equivalent |