Skip to content

Olympus AF Angioscope System

by Olympus Corp. 510(k)

Active United States

510(k) K911278

Overview

The Olympus AF Angioscope System is an endoscope and accessories used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and blood vessels. It is classified as an angioscope with product code LYK and is intended for use in gastroenterology and urology procedures.

The system is supplied by Olympus Corp. and received FDA 510(k) clearance on July 17, 1991, with a decision of substantially equivalent. It is a Class II device under special controls and is not specified as single-use or reusable. The system includes various model numbers and reference codes as specified in the device data.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911278 Date17 Jul 1991ClearedStatusActive

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 · 1 ongoing · FDA

    • Ongoing Z-0330-2024 FDA Class III initiated 25 Sep 2023 via K911278, on the same 510(k)

    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 potential for contamination that could lead to the risk of infection

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

Specification

510(k)

510(k) Number
FDA Product Code
LYK
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 AF Angioscope System used for?

    The Olympus AF Angioscope System is an endoscope designed to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and blood vessels, specifically intended for use in gastroenterology and urology procedures.

  • Is the Olympus AF Angioscope System single-use or reusable?

    The Olympus AF Angioscope System is not specified as single-use or reusable in the device data. The system includes various model numbers and reference codes as specified in the device information.

  • What regulatory approvals does the Olympus AF Angioscope System have?

    The Olympus AF Angioscope System received FDA 510(k) clearance on July 17, 1991, with a decision of substantially equivalent. It is classified as a Class II device under special controls.

  • What models and reference codes are available for the Olympus AF Angioscope System?

    The system includes various model numbers and reference codes as specified in the device data, though specific models are not detailed in the provided information.