Class Class II

Endoscopic Distal Attachment (AF-D series) (K242635)

K242635 2025-05-30 Traditional
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Description

Endoscopic Distal Attachment (AF-D series) by Alton (Shanghai) Medical Instruments Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242635
Clearance Date2025-05-30
Clearance TypeTraditional
Product CodeFDS
Regulation Number876.1500

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Predicate lineage for K242635

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. Endoscopic Distal Attachment (AF-D series) (K242635) 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
K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited2023
K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.2017

Trace the full predicate network for K242635

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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