# K953876: Pentax Ultrasound Endoscope Model FG-32UA (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Nov 24, 1995 after 109 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- 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
No predicates in its family tree.
87 later devices descend from it; 1 cites it directly.
1 of 88 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
- K961974: FG-36UX, Ultrasound Upper GI Fiberscope (1997), 86 descendants of its own
- 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

Source page: https://510kreport.com/device/K953876
Methodology: https://510kreport.com/methodology