510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251927Substantially Equivalent

Zeta Navigation System (ZNS131-US)

Zeta Surgical Inc., Boston MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251927 is the FDA 510(k) clearance record for Zeta Navigation System (ZNS131-US), a class II device, cleared for Zeta Surgical, Inc. on under FDA product code SGE (Extracranial Positional System For A Transcranial Magnetic Stimulation System). FDA's definition for product code SGE reads: "Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system". FDA records list 6 510(k) clearances for Zeta Surgical, Inc., from to . As of , FDA records show no recalls naming K251927.

Clearance record

Decision date
Received
(109 days to decision)
Product code
SGE Extracranial Positional System For A Transcranial Magnetic Stimulation System
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Zeta Surgical, Inc. 280 Summer St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SGE

Trailing 12 months

FDA records hold no clearances under product code SGE in the trailing twelve months.

FDA records show no clearances under product code SGE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SGE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260