510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080386Substantially Equivalent

Columbia 600 Electrode, Columbia 06 Leadwire

Columbia Scientific Development, LLC, Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080386 is the FDA 510(k) clearance record for COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE, a class II device, cleared for Columbia Scientific Development, LLC on under FDA product code GXY (Electrode, Cutaneous). FDA records list one 510(k) clearance for Columbia Scientific Development, LLC. As of , FDA records show no recalls naming K080386.

Clearance record

Decision date
Received
(107 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Columbia Scientific Development, LLC 420 NW 11th Ave., Portland OR
510(k) summary
Summary PDF
Third party review
Yes

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