# K961974: FG-36UX, Ultrasound Upper GI Fiberscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Feb 10, 1997 after 266 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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: 1 generation back to K812810 (1981). 4 ancestors in all.
86 later devices descend from it; 3 cite it directly.
1 of 91 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904573: Pentax Ultrasound Endoscope, Model FG-32UA, Pentax Precision Instrument Corp. (1991) Summary page 1.
- K953876: Pentax Ultrasound Endoscope Model FG-32UA (Modification), Pentax Precision Instrument Corp. (1995) Summary page 1.
- K812810: Pentax Flexible Driodenofiberscope, Pentax Precision Instrument Corp. (1981) Summary page 1.
- K924126: EUB-405, Hitachi Medical Systems America, Inc. (1992) Summary page 1.

## Most influential descendants
- K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center (2001), 59 descendants of its own
- K031347: Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 (2003), 44 descendants of its own
- K042140: Olympus BF Type UC160-OL8 (2004), 43 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K010740: FG-36UX, Fiber Ultrasound Gastroscope (2001), 16 descendants of its own

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2077-2016: 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.
- Apr 6, 2016 · Class II · Z-2279-2016: Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

## Indications for use
The FG-36UX, Ultrasound Fiber Gastroscope, is intended to provide optical and sonographic visualization of and therapeutic access to, the Upper Gastrointestinal Tract. The Upper GI Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when the indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.

Source page: https://510kreport.com/device/K961974
Methodology: https://510kreport.com/methodology