FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUADRIPLEGIC URINARY DRAINAGE VALVE
K Number: K772402
·
Decision Jan 26, 1978
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
17
Applicant Total
278
Review Days
30
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Basic Information
- Device Name
- QUADRIPLEGIC URINARY DRAINAGE VALVE
- K Number
- K772402
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- December 27, 1977
- Decision Date
- January 26, 1978
- Product Code
- FAQ
- 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 |
|---|---|---|---|
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAQ), ordered by most recent decision date.
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
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CONVEEN URINE BAG - STERILE
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PROSYS BEDSIDE DRAINAGE BAG
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PROSYS LEG BAG
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Other Clearances by Fred Sammons, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | May 6, 1988 | Substantially Equivalent |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Apr 1, 1988 | Substantially Equivalent |
| K831549 | ARM SLINGS | Jun 30, 1983 | Substantially Equivalent |
| K831548 | SPLINTS | Jun 27, 1983 | Substantially Equivalent |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Jun 24, 1983 | Substantially Equivalent |
| K831550 | FINGER BONIOMETER BK7506 | Jun 24, 1983 | Substantially Equivalent |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Jun 24, 1983 | Substantially Equivalent |
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Jun 24, 1983 | Substantially Equivalent |
| K831553 | LEG DRAINAGE BAG STRAP BK6011 | Jun 16, 1983 | Substantially Equivalent |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Jun 8, 1983 | Substantially Equivalent |