# K253598: InjecSURE Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Mar 31, 2026 after 133 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: 7 generations back to K820973 (1982). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180214: Repris Bladder Injection System, Uro-1, Inc. (2018) Summary page 5.

## Indications for use
The InjecSURE® Injection System is intended for use as an accessory to currently marketed cystoscopes to allow delivery of injectable materials into urethral tissues of the lower urinary tract during cystoscopic procedures.

Source page: https://510kreport.com/device/K253598
Methodology: https://510kreport.com/methodology