Cleared Traditional

K231254 - GripTract-GI Endoscopic Tissue Manipulator (FDA 510(k) Clearance)

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

K231254 · Actuated Medical, Inc. · Gastroenterology & Urology device
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Nov 2023
Decision
186d
Days
Class 2
Risk

K231254 is an FDA 510(k) clearance for the GripTract-GI Endoscopic Tissue Manipulator. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Actuated Medical, Inc. (Bellefonte, US). The FDA issued a Cleared decision on November 3, 2023 after a review of 186 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 K231254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date November 03, 2023
Days to Decision 186 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 130d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum 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 - FDF Colonoscope And Accessories, Flexible/rigid

All 110
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K231254.
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K244029 · Endorobotics Co., Ltd. · Sep 2025
FUJIFILM Endoscope Model EC-860P/M
K243261 · Fujifilm Corporation · May 2025
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K250432 · Olympus Medical Systems Corporation · May 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110 · Pentax of America, Inc. · Jan 2025
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
K242325 · Actuated Medical, Inc. · Oct 2024