Class Class II

da Vinci Handheld Camera (K241913)

K241913 2024-08-28 Traditional
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Description

da Vinci Handheld Camera by Intuitive Surgical Operations, Inc., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241913
Clearance Date2024-08-28
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500

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Predicate lineage for K241913

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. da Vinci Handheld Camera (K241913) 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
K191043da Vinci Handheld CameraIntuitive Surgical, Inc.2019

Trace the full predicate network for K241913

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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