# K093395: Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound Gastrovideoscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jun 17, 2010 after 230 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954022 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011314: Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System, Aloka Co., Ltd. (2001) Summary page 7.
- K043196: Aloka SSD-Alpha 10 Ultrasound System, Aloka Co., Ltd. (2004) Summary page 7.

## Most influential descendants
- K232518: EndoSound Vision System; EVS (2023), 0 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0333-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Oct 16, 2020 · Class II · Z-0500-2021: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
- Dec 17, 2018 · Class II · Z-1007-2019: The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing oper
- Aug 21, 2015 · Class II · Z-2818-2015: Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope

## Indications for use
This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment. This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

Source page: https://510kreport.com/device/K093395
Methodology: https://510kreport.com/methodology