FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
uVue HSG/SHG Catheter
K Number: K160217
·
Decision Oct 6, 2016
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
175
Review Days
251
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Basic Information
- Device Name
- uVue HSG/SHG Catheter
- K Number
- K160217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- January 29, 2016
- Decision Date
- October 6, 2016
- 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)
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RELIEEV HSG Catheter (HSG7FA1)
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FemVue MINI Saline-Air Device
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RELIEEV Uterine Manipulator Injector (CUMI 5.0)
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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
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