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GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251041

by Actuated Medical, Inc.

Identifiers

510(k) Number
K251041 FDA 510(k)
FDA Product Code
FDS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The GripTract-GI Endoscopic Tissue Manipulator is an accessory that connects to the distal end of an endoscope without occupying the working channel. It is designed to assist clinicians with positioning the distal end of an endoscope from the mucosal surface and to aid with optical visualization, diagnosis, and endoscopic treatment.

This device is a single-use, non-sterile accessory intended for use in upper gastrointestinal procedures. It is classified as a Class II medical device and has received FDA 510(k) clearance with the product code FDS. The device is supplied in various sizes and models, including the Upper GI Model GT-GS100.

Frequently asked questions

What is the purpose of the GripTract-GI Endoscopic Tissue Manipulator?

The GripTract-GI is an accessory that connects to the distal end of an endoscope without occupying the working channel. It assists clinicians with positioning the endoscope from the mucosal surface and aids with optical visualization, diagnosis, and endoscopic treatment during upper gastrointestinal procedures.

Is the GripTract-GI reusable or sterile?

The GripTract-GI is a single-use, non-sterile accessory. It is designed for one-time use during upper gastrointestinal procedures and should not be reused or resterilized to ensure patient safety and device performance.

What sizes and models are available for the GripTract-GI?

The GripTract-GI is available in various sizes and models, including the Upper GI Model GT-GS100. This variety allows clinicians to select the appropriate device for different patient anatomies and procedural requirements during upper gastrointestinal examinations.

How should the GripTract-GI be stored?

The device should be stored in a clean, dry environment at room temperature, away from direct sunlight and extreme temperatures. Proper storage conditions help maintain the integrity of the device until its single-use application during upper gastrointestinal procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - GripTract-GI, GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 ..., GripTract-GI Endoscopic Tissue Manipulator GT-GS100… - FDA.report, Actuated Medical Celebrates First Human Use of GripTract-GI Endoscopic ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Actuated Medical, Inc.

Sources (1)

  • FDA 510(k) K251041 24 fields · synced Sep 22, 2026