510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955335Substantially Equivalent

Disposable Hypodermic Monopolar Needle Recording Electrode

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

K955335 is the FDA 510(k) clearance record for DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE, a class II device, cleared for Chalgren Enterprises, Inc. on under FDA product code IKT (Electrode, Needle, Diagnostic Electromyograph). FDA records list 21 510(k) clearances for Chalgren Enterprises, Inc., from to . As of , FDA records show no recalls naming K955335.

Clearance record

Decision date
Received
(70 days to decision)
Product code
IKT Electrode, Needle, Diagnostic Electromyograph
Regulation
21 CFR 890.1385
Device class
Class II
Review panel
Physical Medicine
Applicant
Chalgren Enterprises, Inc. 8021 Carmel St., Gilroy CA
510(k) summary
Statement
Third party review
No

Clearances, product code IKT

Trailing 12 months
1 clearance under product code IKT in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IKT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260