FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE URETHRAL CATHETERIZATION SET
K Number: K821978
·
Decision Aug 25, 1982
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
49
Review Days
50
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Basic Information
- Device Name
- STERILE URETHRAL CATHETERIZATION SET
- K Number
- K821978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Devices, Inc.
- Date Received
- July 6, 1982
- Decision Date
- August 25, 1982
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNX), ordered by most recent decision date.
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MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
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BESECURE EXTERNAL URINARY COLLECTION SYSTEM
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AMSINO URINARY LEG BAG
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WELCON HUE-VU URINARY DRAINAGE BAG
FDA 510(k)
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·Gastroenterology, Urology
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| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
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