# K120446: Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Aug 13, 2012 after 181 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K822846 (1982). 25 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700, Fujinon, Inc. (2007) Summary page 1.
- K111243: Fujinon Ultrasonic Processor, Fujinon, Inc. (2011) Summary page 2.

## Most influential descendants
- K181763: FUJIFILM Ultrasonic Endoscope (2018), 3 descendants of its own
- K183433: FUJIFILM Ultrasonic Endoscope (2019), 2 descendants of its own
- K221238: FUJIFILM Ultrasonic Endoscope EG-740UT (2022), 0 descendants of its own
- K221952: Endoscope Model EG-580UT and Endoscope Model EG-580UR (2022), 0 descendants of its own

## Recalls of this device
- Jul 31, 2013 · Class II · Z-0112-2014: A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscop

## Indications for use
Fujinon/Fujiflm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujmflm ultrasonic processor. This product is not intended for use on children and infants.

Source page: https://510kreport.com/device/K120446
Methodology: https://510kreport.com/methodology