510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970943Substantially Equivalent

Guideline System

Axon Instruments, Inc., Foster City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970943 is the FDA 510(k) clearance record for GUIDELINE SYSTEM, a class II device, cleared for Axon Instruments, Inc. on under FDA product code GZL (Electrode, Depth). FDA records list 3 510(k) clearances for Axon Instruments, Inc., from to . As of , FDA records show no recalls naming K970943.

Clearance record

Decision date
Received
(157 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Axon Instruments, Inc. 1101 Chess Dr., Foster City CA
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