# K982890: Advanced Uroscience Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Uroscience, Inc.
- Decided: Oct 26, 1998 after 70 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: 2 generations back to K820973 (1982). 4 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843719: Single Wall Introducer Needle, Ocean Medical Products, Ltd. (1984) Summary page 1.
- K960519: Martech Endoscopic Injection Needle, Martech Medical Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K990996: Genyx Medical Injection Needle (1999), 13 descendants of its own
- K022484: Cook Injection Needle (2002), 12 descendants of its own
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (2009), 3 descendants of its own
- K051905: Uroplasty Rigid Endoscopic Needle (2005), 3 descendants of its own
- K090217: Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 (2009), 2 descendants of its own

## Indications for use
The Advanced UroScience Injection needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.

Source page: https://510kreport.com/device/K982890
Methodology: https://510kreport.com/methodology