# K210177: PENTAX Medical Video Upper GI Scopes EG17-J10

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Oct 20, 2021 after 271 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). 29 ancestors in all.
No later device cites it as a predicate yet.
3 of 30 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 5.

## Indications for use
The PENTAX Medical Video Upper GI Scope EG17-J10 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 of esophagus, stomach and duodenum. This endoscope is introduced via the mouth or nose when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

Source page: https://510kreport.com/device/K210177
Methodology: https://510kreport.com/methodology