510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K183123Substantially Equivalent

microTargeting Guideline 4000 5.0 System

FHC, Inc., Bowdoin ME / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183123 is the FDA 510(k) clearance record for microTargeting Guideline 4000 5.0 System, a class II device, cleared for FHC, Inc. on under FDA product code GZL (Electrode, Depth). FDA records list 7 510(k) clearances for FHC, Inc., from to . As of , FDA records show one recall naming K183123.

Clearance record

Decision date
Received
(37 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
FHC, Inc. 1201 Main St., Bowdoin ME
510(k) summary
Summary PDF
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