FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
K Number: K960949
·
Decision Apr 19, 1996
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
1
Review Days
39
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Basic Information
- Device Name
- PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
- K Number
- K960949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bristol-Myers Squibb
- Date Received
- March 11, 1996
- Decision Date
- April 19, 1996
- Product Code
- KNX
- 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
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