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
K915864Substantially Equivalent

Monotrode Cutaneous Electrode

Henley Intl., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915864 is the FDA 510(k) clearance record for MONOTRODE CUTANEOUS ELECTRODE, a class II device, cleared for Henley Intl. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 44 510(k) clearances for Henley Intl., from to . As of , FDA records show no recalls naming K915864.

Clearance record

Decision date
Received
(568 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Henley Intl. 104 Industrial Blvd.,, Sugar Land TX
510(k) summary
Statement
Third party review
No

Clearances, product code GXY

Trailing 12 months
11 clearances under product code GXY in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20260