# K051541: GF-UE160-AL5 Ultrasound Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jul 1, 2005 after 21 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K853585 (1986). 6 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 34 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)
- K971660: Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment, Olympus America, Inc. (1997) Summary page 2.

## Most influential descendants
- K063683: Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope (2007), 15 descendants of its own
- K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 (2007), 8 descendants of its own
- K111243: Fujinon Ultrasonic Processor (2011), 7 descendants of its own
- K092156: Cad 12, Colonoscopy Assist Device (2009), 7 descendants of its own
- K121564: Endoscopic Ultrasound Center EU-Y0006 (2012), 6 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-0507-2021: 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.

## Indications for use
The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. The Aloka SSD-5000 (K033311) is an all-digital diagnostic ultrasonic scanner with a digital beam former supporting gray scale, spectral Doppler and Color Flow imaging. Depending on the probe, the Aloka SSD-5000 may be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Trauma and Surgical applications. The Aloka SSD-5000 is a Track 3 system and is not indicated for ophthalmic applications. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K051541
Methodology: https://510kreport.com/methodology