Cleared Traditional

K251041 - GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251041 · Actuated Medical, Inc. · Gastroenterology & Urology device
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Oct 2025
Decision
211d
Days
Class 2
Risk

K251041 is an FDA 510(k) clearance for the GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Actuated Medical, Inc. (Bellefonte, US). The FDA issued a Cleared decision on October 31, 2025 after a review of 211 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Actuated Medical, Inc. devices

Submission Details

510(k) Number K251041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2025
Decision Date October 31, 2025
Days to Decision 211 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 130d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDS Gastroscope And Accessories, Flexible/rigid

All 74
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K251041.
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K260573 · EvoEndo, Inc. · Apr 2026
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Hood DH-084STR
K253568 · Fujifilm Corporation · Feb 2026
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EvoEndo Single-Use Endoscopy System
K251708 · EvoEndo, Inc. · Oct 2025
Disposable Distal Cap
K243388 · Micro-Tech (Nanjing) Co., Ltd. · Jun 2025