FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
URI-SURE
K Number: K852619
·
Decision Aug 27, 1985
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
12
Review Days
68
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Basic Information
- Device Name
- URI-SURE
- K Number
- K852619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Ashai Co. , Ltd.
- Date Received
- June 20, 1985
- Decision Date
- August 27, 1985
- 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.
IBAG
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4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
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MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
FDA 510(k)
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BESECURE EXTERNAL URINARY COLLECTION SYSTEM
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AMSINO URINARY LEG BAG
FDA 510(k)
FDA Class 2
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WELCON HUE-VU URINARY DRAINAGE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Ashai Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K870428 | AEROSOL ONE, NEBULIZER PUMP | May 15, 1987 | Substantially Equivalent |
| K852622 | AEROSOL ONE | Apr 24, 1986 | Substantially Equivalent |
| K852620 | SAFE.N.SURE | Oct 31, 1985 | Substantially Equivalent |
| K852627 | MAXI-NEB | Sep 26, 1985 | Substantially Equivalent |
| K852628 | NASAL ONE | Sep 18, 1985 | Substantially Equivalent |
| K852625 | OXY-TUBE | Sep 18, 1985 | Substantially Equivalent |
| K852629 | AERO-MASK TWO | Sep 18, 1985 | Substantially Equivalent |
| K852624 | OXY-TWO | Sep 18, 1985 | Substantially Equivalent |
| K852618 | OXY-DIAL | Sep 18, 1985 | Substantially Equivalent |
| K852626 | AERO-MASK ONE | Sep 18, 1985 | Substantially Equivalent |