FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇨 Monaco
RocaTub Ureteral Catheter
K Number: K192183
·
Decision Apr 23, 2020
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
27
Applicant Total
1
Review Days
255
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Basic Information
- Device Name
- RocaTub Ureteral Catheter
- K Number
- K192183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promepal Sam
- Date Received
- August 12, 2019
- Decision Date
- April 23, 2020
- Product Code
- EYB
- 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 |
|---|---|---|---|
| EYB | Catheter, Ureteral, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
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