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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 the device name listed in this FDA 510(k) record. The listed applicant is Actuated Medical, Inc.. It received FDA 510(k) clearance on 2025-10-31 under 510(k) 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. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K251041.

When did GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 receive FDA 510(k) clearance?

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

Who is the listed applicant for GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100?

The FDA 510(k) record lists Actuated Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06015607Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the ColonRECRUITINGNCT07027826The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United StatesRECRUITINGNCT07572253A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial FibrillationNOT_YET_RECRUITING

Other records listing Actuated Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsK231254GripTract-GI Endoscopic Tissue ManipulatorK220890IO Needle Safety SheathK200646TubeClear SystemK172556TubeClear SystemK163092TubeClear Control Box and Clearing Stem

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Related Devices (Code: FDS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm CorporationK253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm CorporationK251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.

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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