FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Modified Novy Cornual Cannulation Set
K Number: K180552
·
Decision Jul 12, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
4
Applicant Total
175
Review Days
133
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Basic Information
- Device Name
- Modified Novy Cornual Cannulation Set
- K Number
- K180552
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- March 1, 2018
- Decision Date
- July 12, 2018
- Product Code
- MOV
- 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 |
|---|---|---|---|
| MOV | Catheters, Salpingography | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOV), ordered by most recent decision date.
ECHOMARK INTRAUTERINE GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NOVY CORNUAL CANNULATION SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OVAMED INTRAUTERINE ACCESS CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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