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

Extracranial Positional System For A Transcranial Magnetic Stimulation System

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

SGE is the FDA product code for Extracranial Positional System For A Transcranial Magnetic Stimulation System, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SGE
Device name
Extracranial Positional System For A Transcranial Magnetic Stimulation System
FDA definition
Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SGE

By decision year
1 clearance under product code SGE with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SGE by decision year
YearClearances
20251

Applicants with the most clearances

Product code SGE
Applicants holding the most 510(k) clearances under product code SGE
ApplicantClearances
Zeta Surgical Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code