510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083756Substantially Equivalent

Guardian 150 Electrode

Spectramed, LLC, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083756 is the FDA 510(k) clearance record for GUARDIAN 150 ELECTRODE, a class II device, cleared for Selectivemed Components, Inc. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 20 510(k) clearances for SPECTRAMED, LLC, from to . As of , FDA records show no recalls naming K083756.

Clearance record

Decision date
Received
(191 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Selectivemed Components, Inc. 845 Aronson Lake Ct., Roswell GA
510(k) summary
Summary PDF
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