510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964644Substantially Equivalent

Ad-Tech's Depth Electrode

AD-Tech Medical Instrument Corp., Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964644 is the FDA 510(k) clearance record for AD-TECH'S DEPTH ELECTRODE, a class II device, cleared for Ad-Tech Medical Instrument Corp on under FDA product code GZL (Electrode, Depth). FDA records list 26 510(k) clearances for Ad-Tech Medical Instrument Corp, from to . As of , FDA records show no recalls naming K964644.

Clearance record

Decision date
Received
(190 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Ad-Tech Medical Instrument Corp 1901 William St.,, Racine WI
510(k) summary
Statement
Third party review
No

Clearances, product code GZL

Trailing 12 months
2 clearances under product code GZL in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZL, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260