FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SUPRAPUBIC CATHETER AND INTRODUCER SET
K Number: K132890
·
Decision Jan 17, 2014
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
31
Applicant Total
4
Review Days
123
Basic Information
- Device Name
- SUPRAPUBIC CATHETER AND INTRODUCER SET
- K Number
- K132890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDIPLUS LTD.
- Date Received
- September 16, 2013
- Decision Date
- January 17, 2014
- Product Code
- KOB
- 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 |
|---|---|---|---|
| KOB | Catheter, Suprapubic (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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