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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medwork GmbH. It received FDA 510(k) clearance on 2021-09-10 under 510(k) 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. The listed applicant is Fujifilm Medwork GmbH. The 510(k) number is K210625.

When did JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve receive FDA 510(k) clearance?

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

Who is the listed applicant for JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve?

The FDA 510(k) record lists Fujifilm Medwork GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Fujifilm Medwork GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221264FROG Forceps Valve (VAL1-F1-100)

Related Devices (Code: ODC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Official Source

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

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