510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K023472Substantially Equivalent

Low Profile EEG Needle Electrode, Models 112-812-18Tp, 112-812-48Tp, 112-812-60Tp, 112-812-72Tp, 112-812-96Tp, 112-812

Class A Enterprises, Inc., Hesperia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023472 is the FDA 510(k) clearance record for LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812, a class II device, cleared for Class A Enterprises, Inc. on under FDA product code GXZ (Electrode, Needle). FDA records list one 510(k) clearance for Class A Enterprises, Inc. As of , FDA records show no recalls naming K023472.

Clearance record

Decision date
Received
(153 days to decision)
Product code
GXZ Electrode, Needle
Regulation
21 CFR 882.1350
Device class
Class II
Review panel
Neurology
Applicant
Class A Enterprises, Inc. P.O. Box 401964-16039, Hesperia CA
510(k) summary
Statement
Third party review
No

Clearances, product code GXZ

Trailing 12 months

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

FDA records show no clearances under product code GXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXZ, 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