# K021886: Olympus Ultrasonic Gastrovideoscope GF Type UC140P-DO5 & Olympus Ultrasonic Gastrofiberscope GF Type UC30P

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Jun 19, 2002 after 12 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Olympus GF-UC140P-DO5 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus EVIS Video System Center, Olympus Light Sources, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract. The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus Light Source, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.

Source page: https://510kreport.com/device/K021886
Methodology: https://510kreport.com/methodology