Class Class II

CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) (K221683)

K221683 2023-01-20 Traditional
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Description

CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) by Olympus Medical Systems Corporation, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221683
Clearance Date2023-01-20
Clearance TypeTraditional
Product CodeFAJ
Regulation Number876.1500

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Predicate lineage for K221683

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) (K221683) cites 1 predicate device and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K133538VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA ...Olympus Corporation of the Americas2014

Later devices that cite this one as their predicate

Devices that cite K221683
K numberDeviceApplicantYear
K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScop...Ambu A/S2025

Trace the full predicate network for K221683

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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