← Back to catalogue

AMD Anti-Fog Solution

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K181887

by Advanced Medical Design Co., Ltd.

Identifiers

510(k) Number
K181887 FDA 510(k)
FDA Product Code
OCT 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 AMD Anti-Fog Solution is a liquid formulation designed to prevent fogging on endoscopy equipment. Classified as an anti-fog solution and accessories under the FDA’s regulation 876.1500, it is intended for use with endoscopy devices to maintain optical clarity during procedures in gastroenterology and urology.

This solution is supplied as a single-use liquid, requiring no sterilization or reprocessing. It is compatible with MRI environments and is available in multiple reference codes (e.g., 3004605321, 1000114185) to accommodate various endoscopy accessories. Storage conditions are not specified but must adhere to manufacturer guidelines to preserve efficacy. The device holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR)

Frequently asked questions

What specialties is the AMD Anti-Fog Solution primarily intended for, and how does it help during procedures?

The AMD Anti-Fog Solution is designed for use in gastroenterology and urology specialties. It prevents fogging on endoscopy equipment, ensuring optical clarity during procedures. This helps maintain visibility of internal structures, improving diagnostic accuracy and procedural efficiency.

Is the AMD Anti-Fog Solution compatible with MRI environments, and how should it be stored?

Yes, the AMD Anti-Fog Solution is explicitly stated as compatible with MRI environments, making it suitable for use in facilities where MRI scans are performed. While storage conditions aren’t specified, it must be handled per the manufacturer’s guidelines to preserve its effectiveness.

How is the AMD Anti-Fog Solution supplied, and is it reusable or single-use?

The AMD Anti-Fog Solution is supplied as a single-use liquid formulation, meaning each application requires a new unit. It does not require sterilization or reprocessing, simplifying workflow and reducing contamination risks.

What regulatory pathways has the AMD Anti-Fog Solution undergone, and what does that mean for its use?

The AMD Anti-Fog Solution holds FDA 510(k) clearance, indicating it has been deemed substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR), ensuring it meets stringent European safety and performance standards. This regulatory status supports its use in both U.S. and EU markets.

Are there multiple versions or sizes of the AMD Anti-Fog Solution, and how do I determine the correct one for my endoscopy accessories?

Yes, the AMD Anti-Fog Solution is available in multiple reference codes (e.g., 3004605321, 1000114185) to accommodate various endoscopy accessories. The correct version should align with the specific device or accessory you’re using—check the manufacturer’s documentation or labeling for compatibility.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Advanced Medical Design Co., Ltd.

Sources (2)

  • FDA 510(k) K181887 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026