Class Class II

PENTAX Medical Video Colonoscope (EC38-i20cWL) (K242110)

K242110 2025-01-03 Traditional
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Description

PENTAX Medical Video Colonoscope (EC38-i20cWL) by Pentax of America, Inc., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242110
Clearance Date2025-01-03
Clearance TypeTraditional
Product CodeFDF
Regulation Number876.1500

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Predicate lineage for K242110

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. PENTAX Medical Video Colonoscope (EC38-i20cWL) (K242110) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical V...Pentax of America, Inc.2023
K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)Pentax Medical Company2014

Trace the full predicate network for K242110

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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