BK-6010 Catheter Tube Holder
by Fred Sammons, Inc. 510(k)
Active
510(k) K801711
Overview
The BK-6010 Catheter Tube Holder is a medical device classified as a collector and accessory for an indwelling catheter. It is designed to secure the catheter tube in place during use.
This device is manufactured by Fred Sammons, Inc. and has received FDA 510(k) clearance under the product code KNX. It is categorized as a Class II device subject to special controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801711 | Date13 Aug 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KNX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5250
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent