Cleared Special

Endolumik Gastric Calibration Tube M Series (EGCT36M) (K240069) - FDA 510(k) Clearance

Also marketed or referenced as:
Endolumik Gastric Calibration Tube M Series (EGCT40M)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240069 · Endolumik · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
30d
Days
Class 2
Risk

K240069 is an FDA 510(k) clearance for the Endolumik Gastric Calibration Tube M Series (EGCT36M). Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Endolumik (Morgantown, US). The FDA issued a Cleared decision on February 8, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Endolumik devices

Submission Details

510(k) Number K240069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2024
Decision Date February 08, 2024
Days to Decision 30 days
Submission Type Special
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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 Consultant

Nilo Medical Consulting Group
Michael Nilo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K240069.
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
K241039 · Reshape Lifesciences · May 2024
ViSiGi LUX (5332)
K234033 · Boehringer Laboratories, LLC · May 2024
Enteral Feeding Sets
K240039 · Hangzhou Primecare Medical Co., Ltd. · Apr 2024
ViSiGi 3D Gastric Sizing Tube
K234145 · Boehringer Laboratories · Jan 2024
AMT G-Tube Balloon Gastrostomy Feeding Device
K222846 · Applied Medical Technology, Inc. · Dec 2023
Entarik Feeding Tube System
K230206 · Gravitas Medical, Inc. · Mar 2023