# K031347: Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: May 9, 2003 after 10 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
Longest line of descent: 6 generations back to K894632 (1989). 40 ancestors in all.
44 later devices descend from it; 1 cites it directly.
1 of 85 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center, Olympus Optical Co., Ltd. (2001) Summary page 5.
- K011314: Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System, Aloka Co., Ltd. (2001) Summary page 5.
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 5.

## Most influential descendants
- 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
- K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System (2007), 11 descendants of its own
- K093195: Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-O (2010), 8 descendants of its own
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), 7 descendants of its own

## Indications for use
Trans-esophageal(non-cardiac) Other 1)Gastrointestinal tract and the surrounding organs

Source page: https://510kreport.com/device/K031347
Methodology: https://510kreport.com/methodology