Skip to content

Defendo Fujifilm 700 Single Use Cleaning Adapter

by Steris Corparation

510(k) K250140

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 NumberK250140 Date20 Feb 2025ClearedStatusActive

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  • Withdrawn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, 26 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 Fujifilm 700 Single Use Cleaning Adapter is an endoscope channel accessory designed for use with Fujifilm 700 endoscopes. It functions as a cleaning adapter to facilitate the maintenance and processing of endoscopic equipment.

This device is supplied non-sterile and is intended for single-use applications. It is packaged in quantities of 50 units per box, identified by product number 100337. The device has received FDA 510(k) clearance.

Other devices from Steris Corparation

Questions

AI-generated answers, 26 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 primary purpose of the Defendo Fujifilm 700 Cleaning Adapter?

    This device is an endoscope channel accessory specifically designed to facilitate the maintenance and processing of Fujifilm 700 endoscopes.

  • Is this cleaning adapter intended for reuse?

    No, the device is intended for single-use applications only to ensure proper hygiene and performance during the processing of endoscopic equipment.

  • How is the product supplied to the facility?

    The adapter is supplied non-sterile and is packaged in quantities of 50 units per box, identified by product number 100337.

  • Has this device received regulatory clearance?

    Yes, the Defendo Fujifilm 700 Single Use Cleaning Adapter has received FDA 510(k) clearance under K250140.