# K011886: Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM 160,

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Aug 27, 2001 after 73 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- 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: 3 generations back to K853585 (1986). 11 ancestors in all.
60 later devices descend from it; 3 cite it directly.
1 of 72 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951994: Olympus EU-M30 Endoscopic Ultrasound Center, Olympus America, Inc. (1996) Summary page 9.
- K971660: Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment, Olympus America, Inc. (1997) Summary page 9.
- K944610: Olympus Ultrasonic Probes, Olympus America, Inc. (1995) Summary page 9.
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use, Olympus America, Inc. (1998) Summary page 9.
- K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract), Olympus Optical, Co. (1998) Summary page 9.
- K001203: Olympus UM 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract, The Olympus Optical Co. (2000) Summary page 9.

## Most influential descendants
- K021204: Olympus BF Type UM40 (2002), 44 descendants of its own
- 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
- K043275: Olympus EU-M60 Eus Exera Endoscopic Ultrasound Center (2004), 16 descendants of its own
- K063683: Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope (2007), 15 descendants of its own

## Recalls of this device
- Oct 16, 2020 · Class II · Z-0504-2021: 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
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: 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: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K011886
Methodology: https://510kreport.com/methodology