ClearPath Disposable Introducer

FDA 510(k) K210251 · Clearmind Biomedical

Substantially Equivalent

510(k) numberK210251

Submission

Device name
ClearPath Disposable Introducer
Applicant
Clearmind Biomedical
Taipei, TW
Received
January 29, 2021
Decision date
April 2, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWG – Endoscope, Neurological
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1480
Specialty
Neurology

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code GWG

510(k)DeviceApplicantDecision
K253602Precision S 4K SinuscopeGWG · Traditional Stryker Endoscopy06/04/2026SE
K253679Hydro Irrigation SystemGWG · Traditional Stryker Instruments05/08/2026SE
K243429HJY VisualNext 3D Endoscopic Vision SystemGWG · Traditional Hjy Smart Medical Device Co., Ltd.05/21/2025SE
K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special Integra LifeSciences Corporation04/09/2025SE
K233391cCeLL - In vivoGWG · Traditional VPIX Medical, Inc.08/21/2024SE
K223615Digital ClarusScope System, Digital NeuroPEN SystemGWG · Traditional Clarus Medical, LLC11/21/2023SE
K232618Aurora Surgiscope SystemGWG · Traditional Rebound Therapeutics Corporation10/27/2023SE
K230125Neuroblade SystemGWG · Traditional Clearmind Biomedical10/13/2023SE
K232159QEVO SystemGWG · Special Carl Zeiss Meditec, AG09/21/2023SE
K222735HJY VisualNext Endoscopic Vision SystemGWG · Traditional Hjy Smart Medical Device Co., Ltd.07/28/2023SE

More from Hjy Smart Medical Device Co., Ltd.

510(k)DeviceDecision
K230125Neuroblade SystemGWG · Traditional 10/13/2023SE
K201308Axonpen, Axonmonitor, Axonbox, TabletGWG · Traditional 11/27/2020SE

Questions and answers

When was ClearPath Disposable Introducer cleared by the FDA?

ClearPath Disposable Introducer (K210251) received a 510(k) decision of Substantially Equivalent on April 2, 2021, 63 days after the submission was received.

What is the product code of K210251?

The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.