# K961564: EG-2940, Video Gastroscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Jul 9, 1996 after 77 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822846 (1982). 5 ancestors in all.
10 later devices descend from it; 1 cites it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951574: EC-3800L, Video Colonoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K850020: Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23, Pentax Precision Instrument Corp. (1985) Summary page 1.
- K934918: Epm-3300 Video Processor, Pentax Precision Instrument Corp. (1994) Summary page 1.

## Most influential descendants
- 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
- K181763: FUJIFILM Ultrasonic Endoscope (2018), 3 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.
- Sep 30, 2011 · Not classified · Z-0819-2012: The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.

## Indications for use
The EG-2940, Video Gastroscope, is intended to provide visualization (via a video monitor) of], and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

Source page: https://510kreport.com/device/K961564
Methodology: https://510kreport.com/methodology