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FDA 510(k)

GripTract-GI Endoscopic Tissue Manipulator

K-Number: K231254 · 2023-11-03

ApplicantActuated Medical, Inc.
Decision Date2023-11-03
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GripTract-GI Endoscopic Tissue Manipulator is a medical device manufactured by Actuated Medical, Inc.. It received FDA 510(k) clearance on 2023-11-03 under approval number K231254. 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?

GripTract-GI Endoscopic Tissue Manipulator is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Actuated Medical, Inc.. The 510(k) number is K231254.

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

GripTract-GI Endoscopic Tissue Manipulator received FDA 510(k) clearance on 2023-11-03, under approval number K231254.

What company makes GripTract-GI Endoscopic Tissue Manipulator?

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

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

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

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Other Devices by Actuated Medical, Inc.

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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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