# K850020: Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Jul 9, 1985 after 186 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961564: EG-2940, Video Gastroscope (1996), 10 descendants of its own
- K013640: EG-3630UR, Ultrasund Video Gastroscope (2002), 9 descendants of its own
- K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 (2007), 8 descendants of its own
- K111243: Fujinon Ultrasonic Processor (2011), 7 descendants of its own
- K120446: Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 (2012), 4 descendants of its own

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2071-2016: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- Jul 17, 2014 · Class II · Z-2290-2014: The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
- Sep 16, 2013 · Class I · Z-0084-2014: PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure wit

Source page: https://510kreport.com/device/K850020
Methodology: https://510kreport.com/methodology