Class Class II

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (K242325)

K242325 2024-10-04 Traditional
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Description

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models by Actuated Medical, Inc., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242325
Clearance Date2024-10-04
Clearance TypeTraditional
Product CodeFDF
Regulation Number876.1500

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Predicate lineage for K242325

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. GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (K242325) 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
K231254GripTract-GI Endoscopic Tissue ManipulatorActuated Medical, Inc.2023

Trace the full predicate network for K242325

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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