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FDA 510(k)

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

K-Number: K251041 · 2025-10-31

ApplicantActuated Medical, Inc.
Decision Date2025-10-31
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 is a medical device manufactured by Actuated Medical, Inc.. It received FDA 510(k) clearance on 2025-10-31 under approval number K251041. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100?

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 is a medical device that received FDA 510(k) clearance on 2025-10-31. It is manufactured by Actuated Medical, Inc.. The 510(k) number is K251041.

When was GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 approved by the FDA?

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 received FDA 510(k) clearance on 2025-10-31, under approval number K251041.

What company makes GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100?

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 is manufactured by Actuated Medical, Inc..

What is the FDA product code for GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100?

The FDA product code for GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 is FDS.

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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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