FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR
K Number: K851470
·
Decision Jun 12, 1985
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
17
Review Days
58
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Basic Information
- Device Name
- BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR
- K Number
- K851470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Lic-Orthion
- Date Received
- April 15, 1985
- Decision Date
- June 12, 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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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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Other Clearances by Lic-Orthion
| K Number | Device Name | ||
|---|---|---|---|
| K891649 | PATIENT EXAMINATION GLOVES (LATEX) | Apr 4, 1989 | Substantially Equivalent |
| K862022 | LIC-ORTHION MULTI-THERAPY TREATMENT TABLE | Jun 19, 1986 | Substantially Equivalent |
| K854730 | DAISY (ABSORBENT INCONTINENCE SHIELD) | Feb 6, 1986 | Substantially Equivalent |
| K854729 | ADAM (ABSORBENT INCONTINENCE SHIELD) | Feb 6, 1986 | Substantially Equivalent |
| K851471 | TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR | Jun 12, 1985 | Substantially Equivalent |
| K843233 | ANATOM SYSTEM | Oct 25, 1984 | Substantially Equivalent |
| K843234 | CITOMAT AUTOCLAVES | Oct 25, 1984 | Substantially Equivalent |
| K830853 | LAVATORY SEAT HEIGHTENER | Jun 8, 1983 | Substantially Equivalent |
| K830849 | OB TILT | Apr 5, 1983 | Substantially Equivalent |
| K830854 | COLLAPSABLE LAVATORY SEAT HEIGHTENER | Apr 5, 1983 | Substantially Equivalent |