510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012850Substantially Equivalent

Recording and Stimulating Electrode

Radionics, A Division of Tyco Healthcare Group LP, Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012850 is the FDA 510(k) clearance record for RECORDING AND STIMULATING ELECTRODE, a class II device, cleared for Radionics, A Division of Tyco Healthcare Group LP on under FDA product code GZL (Electrode, Depth). FDA records list 8 510(k) clearances for Radionics, A Division of Tyco Healthcare Group LP, from to . As of , FDA records show no recalls naming K012850.

Clearance record

Decision date
Received
(87 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Radionics, A Division of Tyco Healthcare Group LP 22 Terry Ave., Burlington MA
510(k) summary
Summary
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