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FDA 510(k)

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

K-Number: K210625 · 2021-09-10

ApplicantFujifilm Medwork GmbH
Decision Date2021-09-10
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve is a medical device manufactured by Fujifilm Medwork GmbH. It received FDA 510(k) clearance on 2021-09-10 under approval number K210625. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve?

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Fujifilm Medwork GmbH. The 510(k) number is K210625.

When was JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve approved by the FDA?

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve received FDA 510(k) clearance on 2021-09-10, under approval number K210625.

What company makes JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve?

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve is manufactured by Fujifilm Medwork GmbH.

What is the FDA product code for JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve?

The FDA product code for JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve is ODC.

Related Clinical Trials

NCT06918509 ASSIST Ethiopia: Feasibility Clinical Investigation of the Odonassist™ Medical Device COMPLETED

Other Devices by Fujifilm Medwork GmbH

K221264FROG Forceps Valve (VAL1-F1-100)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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