# K161147: EndoCure Model EUR078A

- Pathway: 510(k) (Traditional)
- Applicant: Endocure Technologies, Inc.
- Decided: Jun 7, 2016 after 46 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- 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 K912120 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912120: Urf-P2 Ureterorenofiberscope/Choledochofiberscope, Olympus Corp. (1991) Summary page 4.

## Indications for use
The EndoCure Model EUR078A has been designed for endoscopic observation and diagnosis within both the urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct). Therapeutic endoscopic procedures using various kinds of accessories are also possible, and include the ability to extract or fragment stones within these organs.

Source page: https://510kreport.com/device/K161147
Methodology: https://510kreport.com/methodology