510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010019Substantially Equivalent

Sterile Subdermal Needle Electrodes

Nicolet Biomedical, Inc., Stoughton WI / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K010019 is the FDA 510(k) clearance record for STERILE SUBDERMAL NEEDLE ELECTRODES, a class II device, cleared for Nicolet Biomedical, Inc. on under FDA product code GXZ (Electrode, Needle). FDA records list 18 510(k) clearances for Nicolet Biomedical, Inc., from to . As of , FDA records show one recall naming K010019.

Clearance record

Decision date
Received
(76 days to decision)
Product code
GXZ Electrode, Needle
Regulation
21 CFR 882.1350
Device class
Class II
Review panel
Neurology
Applicant
Nicolet Biomedical, Inc. 800 Levanger Ln., Stoughton WI
510(k) summary
Summary
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