ECA Gel Product Reformulation

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

Full name

Eca Gel Prouduct Reformulation

510(k) Number

K802647 ↗

FDA Product Code

GYB

Device Class

Class II

Regulation

21 CFR Part 882.1275

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Uca Lotion

  Not classified

  FDA 510(k) K792490 Active Cleared 22 Feb 1980

• Uca Cream

  Class II

  FDA 510(k) K792489 Active Cleared 5 Feb 1980

• Eca Gel

  Class II

  FDA 510(k) K792488 Active Cleared 5 Feb 1980

• Uca Gel Product Reformaulation

  Class II

  FDA 510(k) K802649 Active Cleared 12 Nov 1980

• Eca Cream

  Class II

  FDA 510(k) K792491 Active Cleared 5 Feb 1980

• Uca Cream Product Reformulation

  Class II

  FDA 510(k) K802648 Active Cleared 26 Nov 1980

See all devices from Vanaray Laboratories, Inc. →

• What is the primary purpose of the ECA Gel Product Reformulation in clinical settings?

  The ECA Gel Product Reformulation is designed to improve electrical conductivity between electrodes and skin during neurological procedures. This enhances signal transmission accuracy for diagnostic or monitoring purposes in neurology applications, ensuring reliable data collection for procedures like EEGs or other neurophysiological tests.

• Is the ECA Gel Product Reformulation sterile, and how is it supplied?

  The ECA Gel Product Reformulation is available in both sterile and non-sterile forms, as specified by the manufacturer. It is supplied as a single-use gel, meaning each package is intended for one-time clinical use to maintain hygiene and prevent cross-contamination.

• What storage conditions should be followed for the ECA Gel Product Reformulation?

  While specific storage instructions are not detailed in the provided data, the ECA Gel Product Reformulation should be stored according to standard pharmaceutical practices for conductive gels. This typically includes keeping it in a cool, dry place, away from direct sunlight, and ensuring the packaging remains intact until use.

• Can the ECA Gel Product Reformulation be used in MRI environments?

  No MRI safety restrictions are noted for the ECA Gel Product Reformulation, meaning it does not contain materials that would interfere with MRI procedures. However, always verify compatibility with your specific MRI system and follow facility protocols to ensure safe use.

• How do I know if this gel is appropriate for my neurology practice?

  The ECA Gel Product Reformulation is authorized under FDA 510(k) clearance (K802647) and classified under product code GYB, specifically for electroconductive media in neurology applications. If your practice involves procedures requiring improved electrical conductivity between electrodes and skin—such as EEGs, nerve conduction studies, or other neurophysiological diagnostics—this reformulation may be suitable. Always consult your facility’s clinical guidelines or a medical device specialist to confirm compatibility with your workflow.