FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOUBLE CLOSED URINARY DRAINAGE SYSTEM
K Number: K883886
·
Decision Dec 19, 1988
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
9
Applicant Total
5
Review Days
97
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Basic Information
- Device Name
- DOUBLE CLOSED URINARY DRAINAGE SYSTEM
- K Number
- K883886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Knight Medical, Inc.
- Date Received
- September 13, 1988
- Decision Date
- December 19, 1988
- Product Code
- FCN
- 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 |
|---|---|---|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCN), ordered by most recent decision date.
STANDARD FOLEY SYSTEM PAK
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CATCO URINARY COLLECTION KIT
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BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
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LAKE FOLEY CATHETERIZATION TRAY
FDA 510(k)
FDA Class 2
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Other Clearances by Knight Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921127 | PANDA NEEDLE CATHETER JEJUNOSTOMY KIT | Jan 4, 1993 | Unknown |
| K903086 | TUBE GASTROSTOMY | Nov 20, 1990 | Substantially Equivalent |
| K883848 | KMI OXY-BAN | Mar 2, 1989 | Substantially Equivalent for Some Indications |
| K862489 | ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE | Sep 23, 1986 | Substantially Equivalent |