Skip to content

Olympus BF Type UC160-OL8

by Olympus Corporation 510(k)

Active United States

510(k) K042140

Overview

The Olympus BF Type UC160-OL8 is an ultrasonic endoscope used for real-time ultrasonic imaging and ultrasound-guided fine needle aspiration (FNA). It processes ultrasonic signals reflected from body tissues and optical images from an internal CCD.

This device is supplied by Olympus Corporation and is authorized under FDA 510(k) K042140. It is a reusable device that contains natural rubber latex in its balloons, which may cause allergic reactions. The device is part of the Endoscopic Ultrasound System product line and is classified under product code ODG.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042140 Date18 Aug 2004ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-3303-2018 FDA Class II initiated 8 Aug 2018 via K042140, on the same 510(k)

    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.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
ODG
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Olympus Corp.

See all devices from Olympus Corp. →

Questions

  • What is the Olympus BF Type UC160-OL8 used for?

    The Olympus BF Type UC160-OL8 is an ultrasonic endoscope designed for real-time ultrasonic imaging and ultrasound-guided fine needle aspiration (FNA) procedures. It processes ultrasonic signals reflected from body tissues and optical images from an internal CCD.

  • Is the Olympus BF Type UC160-OL8 a single-use or reusable device?

    The Olympus BF Type UC160-OL8 is a reusable device. However, it contains natural rubber latex in its balloons, which may cause allergic reactions in sensitive individuals.

  • What regulatory authorization does the Olympus BF Type UC160-OL8 have?

    The Olympus BF Type UC160-OL8 is authorized under FDA 510(k) K042140 and is classified under product code ODG. It is part of the Endoscopic Ultrasound System product line and received a traditional clearance with a decision code of SESE.

  • Which medical specialties is the Olympus BF Type UC160-OL8 intended for?

    The Olympus BF Type UC160-OL8 is intended for use in Gastroenterology and Urology specialties, as indicated by its advisory committee description and the medical specialty fields in its regulatory documentation.