FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
K Number: K890096
·
Decision Jul 14, 1989
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
9
Applicant Total
2
Review Days
185
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Basic Information
- Device Name
- BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
- K Number
- K890096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Inventors Corp., Inc.
- Date Received
- January 10, 1989
- Decision Date
- July 14, 1989
- 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 |
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Other Clearances by Medical Inventors Corp., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915166 | MICROCYCLER | Sep 7, 1994 | Substantially Equivalent |