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ClickClean

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200902

by Medeon Biodesign, Inc.

Identifiers

510(k) Number
K200902 FDA 510(k)
FDA Product Code
GCJ 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)

ClickClean is a single-use, disposable laparoscopic cleaning device designed to maintain optical clarity of the laparoscope during minimally invasive procedures. It features a protective sheath that encases the laparoscope’s lens and is applied in situ to remove debris or fogging without requiring scope removal.

The device is intended for in-situ cleaning of laparoscopes during laparoscopic surgeries, ensuring continuous visual access for the surgeon. Supplied as a sterile, single-use item, it is classified under FDA 510(k) clearance (K200902) with a Special clearance type, adhering to regulatory standards for gastrointestinal and urological applications. No additional storage or preparation is required beyond standard sterile handling.

Frequently asked questions

How is the ClickClean device applied during a laparoscopic procedure, and why is it designed for single-use only?

The ClickClean device is applied in situ—meaning it’s placed directly over the laparoscope’s lens during surgery—without requiring the scope to be removed. Its protective sheath is designed to clean debris or fogging efficiently in one use, ensuring optical clarity for the surgeon. It’s single-use to maintain sterility and prevent cross-contamination between patients, as reusable devices could harbor pathogens or degrade over time, compromising safety and performance.

What types of laparoscopic procedures is the ClickClean device approved for, and how does that relate to its regulatory classification?

The ClickClean device is approved for in-situ cleaning of laparoscopes during minimally invasive procedures in gastrointestinal and urological applications, as indicated by its FDA 510(k) clearance under product code GCJ and advisory committee classification. This classification aligns with its intended use for maintaining visual access in surgeries involving these anatomical regions, where optical clarity is critical.

Does the ClickClean device require any special preparation or storage beyond standard sterile handling, and why?

No additional preparation or storage is required beyond standard sterile handling, as the device is supplied pre-sterilized and ready for immediate use. This design ensures convenience in the operating room, where time efficiency is crucial, and eliminates the risk of contamination if improperly stored or prepared, which could compromise its effectiveness or safety.

Are there different sizes or models of the ClickClean device, and how do I determine which one to use for my laparoscope?

The provided specifications do not list varying sizes or models for the ClickClean device, implying it is designed as a universal single-use sheath compatible with standard laparoscopes. To ensure proper fit, verify compatibility with your specific scope’s lens diameter or consult the manufacturer’s instructions, as improper sizing could reduce cleaning effectiveness or damage the device.

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: ClickClean - Medeon, Projects - Medeon, K200902 FDA 510(k) - ClickClean | Medeon Biodesign, Inc., Medeon Biodesign, Inc.: Official Announcements - Stock Market News, Medeon Biodesign, Inc. FDA 510 (k) Products (2015-2020)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medeon Biodesign, Inc.

Sources (1)

  • FDA 510(k) K200902 24 fields · synced Sep 19, 2026