FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Cook Cystostomy Catheter Set
K Number: K181097
·
Decision Jan 18, 2019
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
31
Applicant Total
175
Review Days
267
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Basic Information
- Device Name
- Cook Cystostomy Catheter Set
- K Number
- K181097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- April 26, 2018
- Decision Date
- January 18, 2019
- 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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