# K022135: Ureteral Access Sheath Set (Uass)

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific Corp
- Decided: Sep 13, 2002 after 74 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Boston Scientific Corporation Imager™ II Urology Torque Catheter: named in the summary without a submission number
- (no number) Applied Medical Applied Forté™ XE Ureteral Access Sheath Set: named in the summary without a submission number

## Most influential descendants
- K122649: Navigator HD Ureteral Access Sheath Set (2012), 24 descendants of its own
- K140323: Navigator HD Ureteral Access Sheath Sets (2014), 21 descendants of its own
- K151084: Well Lead Ureteral Access Sheath (2016), 19 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K230748: Disposable Ureteral Access Sheath (2023), 5 descendants of its own

## Indications for use
The UASS is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract via antegrade and/or retrograde access.

Source page: https://510kreport.com/device/K022135
Methodology: https://510kreport.com/methodology