Class Class II

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K241401)

K241401 2024-08-15 Traditional
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Description

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control by Stryker Endoscopy, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241401
Clearance Date2024-08-15
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500

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Predicate lineage for K241401

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. Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K241401) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K232157Connected OR Hub with Device and Voice Control, SDC4K Infor...Stryker Corporation2023
K230886Connected OR Hub with Device and Voice Control; SDC4K Infor...Stryker Endoscopy2023
K222079Connected OR Hub with Device and Voice Control, SDC4K Infor...Stryker Endoscopy2022

Trace the full predicate network for K241401

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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