Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016438686

FEI Number

3016438686

Entity Name

NEUROONE MEDICAL TECHNOLOGIES CORP.

City/State/Country

Eden Prairie, MN, US

Establishment Address

7599 Anagram Drive, Eden Prairie, MN 55344, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

NeuroOne Medical Technologies Corp. (Owner Number: 10062284)

Owner / Operator Contact Address

7599 Anagram Drive, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251243

PMA Number

N/A

All Registered Proprietary Names

OneRF Ablation System EVO sEEG System OneRF Trigeminal Nerve Radiofrequency Probes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2024-11-07
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2024-11-07
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2020-01-08
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2025-02-04
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2025-09-24

Official Correspondent

Evan Goulet

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NeuroOne Medical Technologies Corp.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020354	Baylis Medical Co., Inc.	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	2002-05-03
K201610	ABBOTT MEDICAL	IonicRF Generator	2020-10-21
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

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1316297	EPIMED INTERNATIONAL, INC.	JOHNSTOWN, NY, US
2182269	St. Jude Medical, Atrial Fibrillation Division, Inc.	Minnetonka, MN, US
1643059	Epimed International, Inc.	Dallas, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016438686. Last updated year: 2026. Please use registration number 3016438686 when referencing this establishment in official correspondence.