# K223072: PENTAX Medical Video Esophagoscope EE17-J10

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Dec 2, 2022 after 63 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921244 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051972: Karl Storz Trans-Nasal Esophagoscope, KARL STORZ Endoscopy-America, Inc. (2005) Summary page 4.

## Indications for use
The PENTAX Medical Video Esophagoscope EE17-JI0 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 and gastro-esophageal junction. 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/K223072
Methodology: https://510kreport.com/methodology