STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL - 48-4000GF

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

510(k) Number

K001705 ↗

FDA Product Code

GYB

Models / Variants

004008

48-4000 2GF

48-4000GF

Device Class

Class II

Regulation

21 CFR Part 882.1275

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Bioshield Blue Powder Free Glove

  Class I

  FDA 510(k) K940254 Active Cleared 23 Mar 1994

• Graham-Field Ultrasound Scanning Gel

  Class II

  FDA 510(k) K944597 Active Cleared 21 Jun 1995

• Bioshield Blue Latex Gloves

  Class I

  FDA 510(k) K940256 Active Cleared 23 Mar 1994

• Graham-Field Conductive ECG Spray

  Class II

  FDA 510(k) K944599 Active Cleared 7 May 1996

• Modification to Statsign Saline Electrolyte Gel, Graham-Field Saline Electrolyte Gel

  Class II

  FDA 510(k) K001593 Active Cleared 14 Jun 2000

• Graham-Field Electrode Conductivity Gel

  Class II

  FDA 510(k) K944598 Active Cleared 7 May 1996

See all devices from Chester Labs, Inc. →