Class Class II

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (K241532)

K241532 2024-10-22 Traditional
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Description

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) by Shanghai SeeGen Photoelectric Technology Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241532
Clearance Date2024-10-22
Clearance TypeTraditional
Product CodeFET
Regulation Number876.1500

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Predicate lineage for K241532

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. Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (K241532) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Techn...2022

Trace the full predicate network for K241532

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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