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Defendo Fujifilm 700 Single Use Valve

by Medivators (A Subsidiary of Steris Corporation)

510(k) K232329

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 NumberK232329 Date21 Dec 2023ClearedStatusActive

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  • Withdrawn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)

Full name
Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
510(k) Number
FDA Product Code
ODC
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 Valve is an endoscope channel accessory, used to control air/water suction functions of an endoscope. It is designed for single-use and is compatible with Fujifilm 700 series endoscopes. The valve is available in different types, including biopsy, air/water, and suction valves, as well as a cleaning adapter and connector.

The Defendo Fujifilm 700 Single Use Valve is supplied in various kits, including a 4-piece kit with 50 units per box. It is intended for use in gastroenterology and urology medical specialties. The device has been authorized with an FDA 510K clearance and is classified as a class 2 device with the regulation number 876.1500.

Other devices from Medivators (A Subsidiary of Steris Corporation)

Questions

AI-generated answers, 1 Oct 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 Fujifilm 700 Single Use Valve used for?

    The Defendo Fujifilm 700 Single Use Valve is used to control air/water suction functions of an endoscope, and is compatible with Fujifilm 700 series endoscopes, in gastroenterology and urology medical specialties.

  • Is the Defendo Fujifilm 700 Single Use Valve supplied in different kits?

    Yes, the Defendo Fujifilm 700 Single Use Valve is supplied in various kits, including a 4-piece kit with 50 units per box.

  • Is the Defendo Fujifilm 700 Single Use Valve intended for single-use or reuse?

    The Defendo Fujifilm 700 Single Use Valve is designed for single-use.