# K241213: PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Dec 6, 2024 after 220 days
- Product code: FDS (Gastroscope 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: 9 generations back to K931154 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
3 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131902: Pentax Video Upper G.I. Scopes (EG Family), Pentax Medical Company (2014) Summary page 6.
- K131855: Pentax Video Colonoscopes (EC Family), Pentax Medical Company (2014) Summary page 6.

## Indications for use
The PENTAX Medical Video Upper Gl Scope EG27-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight. The PENTAX Medical Video Colonoscope EC34-i20cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.

Source page: https://510kreport.com/device/K241213
Methodology: https://510kreport.com/methodology