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DEFENDO Single Use Valve Kit AW/S Valves - 2pc For OLYMPUS EUS (00711900)

by Steris Corporation 2 variants

510(k) K240098

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 · Special NumberK240098 Date9 Feb 2024ClearedStatusActive

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  • Withdrawn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
ODC
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Defendo Single Use Valve Kit is an endoscope channel accessory, consisting of an Air/Water Valve and a Suction Valve, designed for use with Olympus echoendoscopes. It controls air/CO2 insufflation, lens washing, and distal balloon inflation. The kit is compatible with Olympus EUS endoscopes that contain a balloon channel.

The Defendo Single Use Valve Kit is supplied in a 2-piece kit, packaged with 25 units per box. It is a single-use device, and its use is intended for controlling an endoscope's air/water suction functions. The device has been assigned a product code of ODC and a regulation number of 876.1500.

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Questions

AI-generated answers, 27 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 Defendo Valve Kit used for?

    The Defendo Valve Kit is used to control air/CO2 insufflation, lens washing, and distal balloon inflation for Olympus EUS endoscopes.

  • Is the Defendo Valve Kit reusable?

    No, the Defendo Valve Kit is a single-use device.

  • How is the Defendo Valve Kit supplied?

    The Defendo Valve Kit is supplied in a 2-piece kit, with 25 units per box.

  • What type of endoscopes is the Defendo Valve Kit compatible with?

    The Defendo Valve Kit is compatible with Olympus EUS endoscopes that contain a balloon channel.