# K180214: Repris Bladder Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Uro-1, Inc.
- Decided: May 3, 2018 after 98 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: 6 generations back to K820973 (1982). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip, Laborie Medical Technologies, Ltd. (2009) Summary page 4.

## Most influential descendants
- K253598: InjecSURE Injection System (2026), 0 descendants of its own

## Indications for use
The Repris Bladder Injection System is indicated for injection of drugs to address abnormal physiology in the lower urinary tract of adults. It is intended to deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. It is provided sterile for single use.

Source page: https://510kreport.com/device/K180214
Methodology: https://510kreport.com/methodology