# K961568: ED-344OT

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Jul 9, 1996 after 77 days
- Product code: FDT (Duodenoscope 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: 2 generations back to K822846 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951574: EC-3800L, Video Colonoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K832006: Pentax FD-34A Duodenofiberscope, Pentax Precision Instrument Corp. (1983) Summary page 1.
- K934918: Epm-3300 Video Processor, Pentax Precision Instrument Corp. (1994) Summary page 1.

## Indications for use
The ED-3440T, Video Duodenoscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper Gastrointestinal Tract and Biliary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

Source page: https://510kreport.com/device/K961568
Methodology: https://510kreport.com/methodology