FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
K Number: K130758
·
Decision Dec 11, 2013
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
4
Review Days
266
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Basic Information
- Device Name
- KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
- K Number
- K130758
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kronner Prototypes, Inc.
- Date Received
- March 20, 2013
- Decision Date
- December 11, 2013
- 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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