510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991522Substantially Equivalent

Microtargeting Electrode

FHC, Inc., Bowdoinham ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991522 is the FDA 510(k) clearance record for MICROTARGETING ELECTRODE, a class II device, cleared for FHC, Inc. on under FDA product code GZL (Electrode, Depth). FDA records list 5 510(k) clearances for FHC, Inc., from to . As of , FDA records show 3 recalls naming K991522.

Clearance record

Decision date
Received
(459 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
FHC, Inc. 9 Main St., Bowdoinham ME
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