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DiLumen C2 - DiLumen Tool Mount

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173317

by Lumendi Llc

Identifiers

510(k) Number
K173317 FDA 510(k)
FDA Product Code
FDF FDA 510(k)
Models / Variants
DiLumen C2 FDA 510(k)
DiLumen Tool Mount FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The DiLumen C2 Tool Mount is a flexible/rigid colonoscope accessory designed to facilitate endoscope positioning within the large intestine. It aids in optical visualization, diagnostic procedures, and endoscopic treatments by ensuring proper alignment and stability of the endoscope during use.

This device is supplied as a single-use, disposable accessory and is intended for use in sterile endoscopic settings. It is classified as a Class II medical device under FDA regulations (21 CFR 876.1500) and has received FDA 510(k) clearance (K173317). The tool mount is compatible with monopolar electrosurgical instruments for cutting, dissecting, and cauterizing tissue within the digestive tract.

Frequently asked questions

What is the DiLumen C2 Tool Mount primarily used for during endoscopic procedures?

The DiLumen C2 Tool Mount is designed to assist in positioning and stabilizing a colonoscope within the large intestine, improving optical visualization and access for diagnostic and therapeutic tasks. It helps align the endoscope during procedures like biopsies, tissue dissection, or cauterization, particularly when used with monopolar electrosurgical instruments.

Is the DiLumen C2 Tool Mount intended for reuse, or is it meant to be used only once?

The DiLumen C2 Tool Mount is explicitly labeled as a single-use, disposable accessory. It is intended for sterile endoscopic settings only, ensuring patient safety and compliance with infection control protocols.

What types of endoscopes is the DiLumen C2 Tool Mount compatible with?

While the device is specifically designed as an accessory for flexible/rigid colonoscopes, its exact compatibility depends on the endoscope’s tool mount interface. The DiLumen C2 is engineered to work with standard colonoscope attachments, but verification with the endoscope manufacturer is recommended to confirm proper fit and function.

How should the DiLumen C2 Tool Mount be stored before use?

Since it is a single-use, sterile disposable device, the DiLumen C2 Tool Mount should be stored in its original, sealed packaging until ready for use. The packaging is designed to maintain sterility, so it should remain unopened until immediately prior to the procedure.

What regulatory pathway was followed for FDA clearance of the DiLumen C2 Tool Mount?

The DiLumen C2 Tool Mount received FDA 510(k) clearance through a traditional review process, determined to be *substantially equivalent* to a legally marketed predicate device. The submission was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, and the device is classified as a Class II medical device under 21 CFR 876.1500.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DiLumen C2; DiLumen Tool Mount (K173317) — FDA 510 (k) | Innolitics, C1 & C2 - Lumendi, DiLumen C² - Lumendi, DiLumen C2 and Tool Mount by Lumendi, LLC | FDA 510(k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lumendi Llc
FDA Applicant
Lumendi, LLC

Sources (1)

  • FDA 510(k) K173317 24 fields · synced Sep 19, 2026