510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981820Substantially Equivalent

Neuromap

Radionics, Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981820 is the FDA 510(k) clearance record for NEUROMAP, a class II device, cleared for Radionics, Inc. on under FDA product code GZL (Electrode, Depth). FDA records list 57 510(k) clearances for Radionics, Inc., from to . As of , FDA records show no recalls naming K981820.

Clearance record

Decision date
Received
(182 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Radionics, Inc. 22 Terry Ave., Burlington MA
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