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Evis Exera Colonovideoscope Model XCF-Q160W1L/1

by Aizu Olympus Co., Ltd.

510(k) K043487

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043487 Date28 Jan 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Evis Exera Colonovideoscope Model Xcf-q160w1l/1 is a flexible endoscope for lower GI tract visualization and surgery, capturing optical images of the colon and rectum and transmitting them to an external video system center, light source, and monitor for physician viewing. It is designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories, and ancillary equipment for endoscopy and endoscopic procedures.

The device is supplied as a single unit, with no specified storage or sterility requirements provided. It is regulated under product code FDF and has been assigned a regulation number of 876.1500. The device has been authorized under FDA 510K, with a decision date of 2005-01-28 and a k number of K043487. The device is intended for use in gastroenterology and urology settings.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Evis Exera Colonovideoscope used for?

    The Evis Exera Colonovideoscope is used for lower GI tract visualization and surgery, capturing optical images of the colon and rectum.

  • Is the device supplied sterile?

    No sterility requirements are provided for the device, and it is supplied as a single unit.

  • What settings is the device intended for use in?

    The device is intended for use in gastroenterology and urology settings.

  • What is the product code for the device?

    The product code for the device is FDF, with a regulation number of 876.1500.