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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 the device name listed in this FDA 510(k) record. The listed applicant is Lumendi, LLC. It received FDA 510(k) clearance on 2023-02-10 under 510(k) 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. The listed applicant is Lumendi, LLC. The 510(k) number is K221452.

When did DiLumen C1, EZ1 and Tool Mount receive FDA 510(k) clearance?

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

Who is the listed applicant for DiLumen C1, EZ1 and Tool Mount?

The FDA 510(k) record lists Lumendi, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Lumendi, LLC 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.

K211819DiLumen C2 and Tool MountK210851DiLumen Endolumenal Interventional Platform (DiLumen)K183112DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)K182540DiLumen Endolumenal Interventional PlatformK173405DiLumen Endolumenal Interventional Scissors (DiLumen Is)K173317DiLumen C2; DiLumen Tool Mount

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Related Devices (Code: FDF)

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.

K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm CorporationK250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)Olympus Medical Systems Corporation

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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