Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015449142

FEI Number

3015449142

Entity Name

CLEARMIND BIOMEDICAL

City/State/Country

Taipei City, TW

Establishment Address

5F, No. 167, Fuxing N. Rd., Songshan Dist. Taipei City, Taiwan (R.O.C.), Taipei City 105403, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CLEARMIND BIOMEDICAL (Owner Number: 10082062)

Owner / Operator Contact Address

5F, No. 167, Fuxing N. Rd., Songshan Dist. Taipei City, Taiwan (R.O.C.), Taipei City, TW-TPE 105403, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210251

PMA Number

N/A

All Registered Proprietary Names

Neuroblade System Axonpen, Axonmonitor, Axonbox, Tablet Axonpen System ClearPath Disposable Introducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2023-10-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-20
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2021-06-11
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2021-06-11

Official Correspondent

Lowry Chen

US Agent Details

Craig Coombs Business: Coombs Medical Device Consulting, Inc Email: CraigJCoombs@Gmail.com Phone: (650) 3802474

Related Public Records

Same Entity

CLEARMIND BIOMEDICAL

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
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3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE
2011171	Sterigenics US LLC	Los Angeles, CA, US
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015449142. Last updated year: 2026. Please use registration number 3015449142 when referencing this establishment in official correspondence.