# K232028: Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

- Pathway: 510(k) (Traditional)
- Applicant: Iq Endoscopes Limited
- Decided: Nov 17, 2023 after 133 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: 11 generations back to K931154 (1993). 42 ancestors in all.
No later device cites it as a predicate yet.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603, Fujifilm Corporation (2018) Summary page 5.
- K163675: Processor VP-7000, Light Source BL-7000, Fujifilm Medical System U.S.A., Inc. (2017) Summary page 5.

## Indications for use
IQ Endoscope’s Gastroscope is intended to provide a live video stream in the upper gastrointestinal (GI) tract of adult patients to facilitate diagnosis of conditions in a clinical setting. The device contains a working channel which facilitates the capability to perform diagnostic/ therapeutic procedures of the upper GI tract. The device is sterile and single use and is not intended on being reprocessed. IQ Endoscope’s Q Base Q-100 Base Unit is designed to be used with IQ Endoscope’s Q Vision G-100 Gastroscope and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the upper digestive tract. IQ Endoscope’s Q Base Q-100 Unit is a reusable device intended to provide compressed air, power, and data connectivity to IQ Endoscope’s Q Vision G-100 Gastroscope to facilitate diagnosis of conditions in a clinical setting.

Source page: https://510kreport.com/device/K232028
Methodology: https://510kreport.com/methodology