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FDA 510(k)

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models

K-Number: K242325 · 2024-10-04

ApplicantActuated Medical, Inc.
Decision Date2024-10-04
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models is a medical device manufactured by Actuated Medical, Inc.. It received FDA 510(k) clearance on 2024-10-04 under approval number K242325. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GripTract-GI Endoscopic Tissue Manipulator Lower GI Models?

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models is a medical device that received FDA 510(k) clearance on 2024-10-04. It is manufactured by Actuated Medical, Inc.. The 510(k) number is K242325.

When was GripTract-GI Endoscopic Tissue Manipulator Lower GI Models approved by the FDA?

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models received FDA 510(k) clearance on 2024-10-04, under approval number K242325.

What company makes GripTract-GI Endoscopic Tissue Manipulator Lower GI Models?

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models is manufactured by Actuated Medical, Inc..

What is the FDA product code for GripTract-GI Endoscopic Tissue Manipulator Lower GI Models?

The FDA product code for GripTract-GI Endoscopic Tissue Manipulator Lower GI Models is FDF.

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Related PubMed Literature

PMID: 41028165 Validation and reliability of mechanical stiffness assessment tools in multilayered polyurethane phantom models of healthy and diabetic plantar soft tissues. Scientific reports (2025)

Other Devices by Actuated Medical, Inc.

K163092TubeClear Control Box and Clearing Stem K172556TubeClear System K200646TubeClear System K220890IO Needle Safety Sheath K231254GripTract-GI Endoscopic Tissue Manipulator K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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