ECG & Ultrasound Gels, Creams & Lotion

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K803151 ↗

FDA Product Code

GYB

Device Class

Class II

Regulation

21 CFR Part 882.1275

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Microscope Slides

  Class I

  FDA 510(k) K862112 Active Cleared 13 Jun 1986

• Sterile IV Set 4 Sizes

  Class II

  FDA 510(k) K832329 Active Cleared 24 Aug 1983

• Sterile, Foley Catheters W/Ptfe Coat

  Class II

  FDA 510(k) K841678 Active Cleared 19 Jul 1984

• Instrument Lubricant

  Not classified

  FDA 510(k) K780610 Active Cleared 31 May 1978

• Abco Mercurial Sphygmomanometer

  Class II

  FDA 510(k) K800236 Active Cleared 22 Feb 1980

• Abco Midstream Urine Collection Set

  Class I

  FDA 510(k) K800233 Active Cleared 26 Feb 1980

See all devices from Abco Dealers, Inc. →

• What is the primary purpose of these ECG & ultrasound gels, creams, and lotions?

  These products serve as an electroconductive interface between the skin and diagnostic equipment. They enhance the transmission of electrical signals during electrocardiogram (ECG) and ultrasound procedures by lowering impedance and improving signal clarity. This ensures accurate diagnostic imaging and monitoring, making them essential for clinical settings like hospitals, diagnostic centers, and physician offices.

• Are these products available in single-use or multi-use formulations?

  Yes, these ECG & ultrasound gels, creams, and lotions are supplied in both single-use and multi-use formulations. The choice depends on clinical needs, infection control protocols, and usage frequency. Single-use options are ideal for reducing cross-contamination risks, while multi-use formulations may be cost-effective for high-volume settings where proper sterilization and maintenance are ensured.

• How are these products typically packaged, and are they sterile?

  The packaging specifications for sterility are not explicitly detailed in the provided data, but electroconductive gels, creams, and lotions are commonly available in both sterile and non-sterile forms. Sterile packaging is typically used for invasive or high-risk procedures to minimize infection risks, while non-sterile formulations may be suitable for non-invasive applications where contamination is less of a concern. Always verify packaging instructions for your specific formulation.

• What variations exist among these products, and how do I identify the correct one for my needs?

  This product line includes multiple formulations, sizes, and variants, each associated with unique registration numbers and product codes (e.g., GYB). Variations may differ in consistency (gels, creams, lotions), conductivity properties, or intended use (e.g., ECG-only vs. ultrasound-compatible). Check the label or packaging for specific registration numbers or consult manufacturer documentation to ensure compatibility with your diagnostic equipment and procedure requirements.

• What regulatory pathway does this device follow, and is it FDA-cleared?

  This device is regulated under the FDA 510(k) clearance pathway and falls under Regulation 882.1275, classified as a Class II device. It holds an FDA 510(k) clearance with the number K803151, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. Always verify the latest regulatory status with the manufacturer or FDA records for your specific product variant.