Ureteral Access Sheath Set (UASS)
510(k) K022135
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022135 | Date13 Sep 2002 | StatusActive |
Official records
- FDA 510(k) database K022135
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KOD
- FDA applicant
- Boston Scientific Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
A Ureteral Access Sheath Set (UASS) is a catheter-based urological device designed to facilitate the passage of endoscopes and urological instruments during endoscopic procedures, and to enable the injection of fluids into the urinary tract. It is classified as a Class II medical device under FDA regulation number 876.5130 and has been determined to be substantially equivalent to a legally marketed predicate device.
The device is supplied as a set and is intended for use in urology and gastroenterology procedures. It is manufactured by Boston Scientific and received FDA 510(k) clearance (K022135) on September 13, 2002, following submission on July 1, 2002. The device is not described as sterile, single-use, reusable, or MRI-safe in the provided data, and no specific sizes, storage conditions, or clinical indications beyond its general use in endoscopic procedures are specified.