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FDA 510(k)

DiLumen C1, EZ1 and Tool Mount

K-Number: K221452 · 2023-02-10

ApplicantLumendi, LLC
Decision Date2023-02-10
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DiLumen C1, EZ1 and Tool Mount is a medical device manufactured by Lumendi, LLC. It received FDA 510(k) clearance on 2023-02-10 under approval number K221452. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DiLumen C1, EZ1 and Tool Mount?

DiLumen C1, EZ1 and Tool Mount is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Lumendi, LLC. The 510(k) number is K221452.

When was DiLumen C1, EZ1 and Tool Mount approved by the FDA?

DiLumen C1, EZ1 and Tool Mount received FDA 510(k) clearance on 2023-02-10, under approval number K221452.

What company makes DiLumen C1, EZ1 and Tool Mount?

DiLumen C1, EZ1 and Tool Mount is manufactured by Lumendi, LLC.

What is the FDA product code for DiLumen C1, EZ1 and Tool Mount?

The FDA product code for DiLumen C1, EZ1 and Tool Mount is FDF.

Other Devices by Lumendi, LLC

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Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.

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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