FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Uro-V Cystoscope
K Number: K171500
·
Decision Jan 30, 2018
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
79
Applicant Total
5
Review Days
252
Basic Information
- Device Name
- Uro-V Cystoscope
- K Number
- K171500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- UroViu Corporation
- Date Received
- May 23, 2017
- Decision Date
- January 30, 2018
- Product Code
- FAJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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