# K002573: Advanced Uroscience Innersheath

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Uroscience, Inc.
- Decided: Nov 16, 2000 after 90 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930827 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930827: Bard Stabilizing Cannula, C.R. Bard, Inc. (1993) Summary page 4.

## Indications for use
Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.

Source page: https://510kreport.com/device/K002573
Methodology: https://510kreport.com/methodology