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JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210625

by FUJIFILM medwork GmbH

Identifiers

510(k) Number
K210625 FDA 510(k)
FDA Product Code
ODC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The JAZZ Suction Valve, JAZZ Air/Water Valve, and JAZZ Forceps Valve are endoscope channel accessories. These devices are designed to facilitate the passage of endotherapy instruments, prevent the backflow or leakage of air and fluids, and enable the suction function of compatible gastrointestinal endoscopes.

These devices are supplied as part of a disposable valve kit for use with Fujifilm 700 Series endoscopes. They are intended for single-use applications. This product has received FDA 510(k) clearance.

Frequently asked questions

What are the JAZZ valves used for?

These devices are endoscope channel accessories designed to facilitate the passage of endotherapy instruments, enable the suction function of compatible gastrointestinal endoscopes, and prevent the backflow or leakage of air and fluids.

Are these valves intended for single-use or reuse?

The JAZZ Suction, Air/Water, and Forceps valves are intended for single-use applications only. They are supplied as part of a disposable valve kit.

Which endoscopes are compatible with this valve kit?

The JAZZ valve kit is specifically designed for use with Fujifilm 700 Series endoscopes.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve (K210625 ..., JAZZ Disposable Valve Kit - endoscopy-app-us.fujifilm.com, JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve, JAZZ Suction Valve, JAZZ Air/Water Valv... (K210625) - FDA 510 (k), JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
FUJIFILM medwork GmbH

Sources (1)

  • FDA 510(k) K210625 24 fields · synced Sep 24, 2026