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Polygel Ultrasound Gel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K851895

by Parker Laboratories, Inc.

Identifiers

510(k) Number
K851895 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Polygel Ultrasound Gel is a coupling agent classified as an Ultrasound Transmission Medium (Product Code: IYO), designed to facilitate acoustic transmission between ultrasound transducers and patient skin during diagnostic and therapeutic imaging procedures. It eliminates air gaps that can disrupt sound wave propagation, ensuring optimal image clarity and diagnostic accuracy. Formulated as a non-conductive gel, it is specifically engineered for use with ultrasound systems to enhance imaging quality without interfering with signal transmission.

This gel is supplied in sterile, single-use packaging for direct application between the transducer and skin during ultrasound examinations. It is intended for use in clinical settings, including radiology departments and diagnostic imaging centers, and complies with FDA 510(k) clearance (K851895) under the Radiology Advisory Committee. The product is non-reusable and must be discarded after a single use to maintain sterility and performance. No MRI safety information is specified, and storage conditions are not detailed in the regulatory data.

Frequently asked questions

What is Polygel Ultrasound Gel used for?

Polygel Ultrasound Gel is designed as a coupling agent to improve acoustic transmission between ultrasound transducers and patient skin. It eliminates air gaps that can interfere with sound wave propagation, ensuring clearer and more accurate diagnostic images during ultrasound examinations. This is particularly useful in radiology departments and imaging centers where high-quality imaging is critical.

How is Polygel Ultrasound Gel supplied and should it be reused?

Polygel Ultrasound Gel is supplied in sterile, single-use packaging, meaning each package is intended for one application only. Reusing the gel is not recommended because it compromises sterility and performance. After use, the gel must be discarded to maintain optimal imaging results and adhere to clinical hygiene standards.

Is Polygel Ultrasound Gel safe for use with all ultrasound systems?

Polygel Ultrasound Gel is specifically formulated as a non-conductive gel to enhance imaging quality without interfering with signal transmission in ultrasound systems. While it is designed to work with standard diagnostic and therapeutic ultrasound equipment, users should confirm compatibility with their specific system. The gel is not intended for MRI use, as no MRI safety information is provided.

What storage conditions should be followed for Polygel Ultrasound Gel?

The regulatory data for Polygel Ultrasound Gel does not specify detailed storage conditions. However, as with most sterile medical products, it should be stored in a clean, dry environment protected from extreme temperatures and direct sunlight. Always follow manufacturer guidelines if additional storage instructions are provided elsewhere.

What regulatory approval does Polygel Ultrasound Gel have?

Polygel Ultrasound Gel holds FDA 510(k) clearance under the Radiology Advisory Committee, with the clearance number K851895. This classification indicates that the device is considered substantially equivalent to legally marketed predecessors in terms of technology and safety. The product is categorized under Product Code IYO as an Ultrasound Transmission Medium.

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: Parker Laboratories | Ultrasound Gels & Medical Products, Ultrasound - ParkerLabs, Parker Polygel Ultrasound Gel - allmed.wiki, FDA Browser - Cleared 510 (K) - POLYGEL ULTRASOUND GEL (K851895), PARKER LABS POLYSONIC® ULTRASOUND LOTION - Pain Super Store

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Parker Laboratories, Inc.

Sources (1)

  • FDA 510(k) K851895 24 fields · synced Oct 1, 2026