FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VALVE FOR CLOSED SYS. URINARY DRAINAGE
K Number: K770399
·
Decision Mar 9, 1977
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
14
Review Days
7
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Basic Information
- Device Name
- VALVE FOR CLOSED SYS. URINARY DRAINAGE
- K Number
- K770399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Will Ross Co.
- Date Received
- March 2, 1977
- Decision Date
- March 9, 1977
- 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
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WELCON HUE-VU URINARY DRAINAGE BAG
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Other Clearances by Will Ross Co.
| K Number | Device Name | ||
|---|---|---|---|
| K780850 | SEARLE NEONATAL OXYGEN PROBE | Aug 23, 1978 | Substantially Equivalent |
| K771561 | DOVER URINE METER | Sep 7, 1977 | Substantially Equivalent |
| K771132 | KENWOOD BIOLOGICAL STEOILIZ. INDICATOR | Jul 14, 1977 | Substantially Equivalent |
| K770611 | PARALLEL BARS | Apr 8, 1977 | Substantially Equivalent |
| K770612 | SPLINT, BOHLER | Apr 8, 1977 | Substantially Equivalent |
| K770607 | TRACTION HARNESS | Apr 8, 1977 | Substantially Equivalent |
| K770608 | WALKING AID | Apr 8, 1977 | Substantially Equivalent |
| K770610 | TABLE, TREATMENT & TRACTION, HI-LO | Apr 8, 1977 | Substantially Equivalent |
| K770609 | TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT | Apr 8, 1977 | Substantially Equivalent |
| K770509 | TABLE, MASSAGE AND TREATMENT | Apr 5, 1977 | Substantially Equivalent |