510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953356Substantially Equivalent

EMG Recording Ring Electrode

Chalgren Enterprises, Inc., Gilroy CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953356 is the FDA 510(k) clearance record for EMG RECORDING RING ELECTRODE, a class II device, cleared for Chalgren Enterprises, Inc. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 21 510(k) clearances for Chalgren Enterprises, Inc., from to . As of , FDA records show no recalls naming K953356.

Clearance record

Decision date
Received
(189 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Chalgren Enterprises, Inc. 8021 Carmel St., Gilroy CA
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