510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K001705Substantially Equivalent

Statsign Electrode Conductivity Gel, Graham-Field Electrode Conductivity Gel, Models 004008, 48-4000 2Gf, 48-4000Gf

Chester Labs, Inc., Cincinnati OH / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001705 is the FDA 510(k) clearance record for STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF, a class II device, cleared for Chester Labs, Inc. on under FDA product code GYB (Media, Electroconductive). FDA records list 11 510(k) clearances for Chester Labs, Inc., from to . As of , FDA records show no recalls naming K001705.

Clearance record

Decision date
Received
(24 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Chester Labs, Inc. 1900 Section Rd., Suite A, Cincinnati OH
510(k) summary
Statement
Third party review
No

Clearances, product code GYB

Trailing 12 months

FDA records hold no clearances under product code GYB in the trailing twelve months.

FDA records show no clearances under product code GYB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260