Bescure
by U-T, Inc. 510(k)
Active
510(k) K863739
Overview
Bescure is a Collector, Urine, (And Accessories) For Indwelling Catheter, classified as a Class II medical device under FDA regulation number 876.5250. It is identified by the product code KNX and was cleared via the traditional 510(k) pathway as substantially equivalent to a predicate device.
The device was manufactured by U-T, Inc. and received FDA 510(k) clearance under K863739 on October 24, 1986. It is associated with the Gastroenterology and Urology advisory committees and is registered under multiple facility establishment identifiers (FEIs).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863739 | Date24 Oct 1986 | 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- Withdrawn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
Questions
What is the BESCURE device used for?
The BESCURE device is a collector for urine and its accessories, designed for use with indwelling catheters to collect and manage urine output in clinical settings.
How is the BESCURE device supplied and is it sterile or single-use?
The device data does not specify sterility, single-use status, or supply format; therefore, no details about packaging, sterility, or reuse can be confirmed from the provided information.
What regulatory pathway was used to clear the BESCURE device?
The BESCURE device was cleared via the traditional 510(k) pathway as substantially equivalent to a predicate device, receiving FDA clearance under K863739 on October 24, 1986.