# K060475: Evis Exera Ultrasonic Bronchofibervideoscope, Olympus Model BF Type UC160F-OL8

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corporation
- Decided: Mar 17, 2006 after 22 days
- Product code: ODB (Endoscopic Contamination Prevention Sheath)
- 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
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.

## Recalls of this device
- Aug 8, 2018 · Class II · Z-3303-2018: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

## Indications for use
Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K060475
Methodology: https://510kreport.com/methodology