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Actuated Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100October 31, 2025
K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsOctober 4, 2024
K231254GripTract-GI Endoscopic Tissue ManipulatorNovember 3, 2023
K220890IO Needle Safety SheathOctober 31, 2022
K200646TubeClear SystemDecember 4, 2020
K172556TubeClear SystemJune 29, 2018
K163092TubeClear Control Box and Clearing StemNovember 30, 2016
K131052TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)August 16, 2013
K123659TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)December 20, 2012
K121571TUBECLEARJune 13, 2012