FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BK-6010 CATHETER TUBE HOLDER
K Number: K801711
·
Decision Aug 13, 1980
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
278
Review Days
20
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Basic Information
- Device Name
- BK-6010 CATHETER TUBE HOLDER
- K Number
- K801711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- July 24, 1980
- Decision Date
- August 13, 1980
- 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 |
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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 |