# K091391: Uroplasty Rigid Endoscopic Needle, MRN-518

- Pathway: 510(k) (Traditional)
- Applicant: Uroplasty, Inc.
- Decided: Jun 30, 2009 after 50 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: 4 generations back to K820973 (1982). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051905: Uroplasty Rigid Endoscopic Needle, Uroplasty, Inc. (2005)

## Most influential descendants
- K121337: Uroplasty Rigid Endoscpic Needles (2012), 0 descendants of its own

## Indications for use
The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

Source page: https://510kreport.com/device/K091391
Methodology: https://510kreport.com/methodology