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FDA 510(k)

ClearPath Disposable Introducer

K-Number: K210251 · 2021-04-02

ApplicantClearmind Biomedical
Decision Date2021-04-02
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ClearPath Disposable Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Clearmind Biomedical. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K210251. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearPath Disposable Introducer?

ClearPath Disposable Introducer is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Clearmind Biomedical. The 510(k) number is K210251.

When did ClearPath Disposable Introducer receive FDA 510(k) clearance?

ClearPath Disposable Introducer received FDA 510(k) clearance on 2021-04-02, under 510(k) number K210251.

Who is the listed applicant for ClearPath Disposable Introducer?

The FDA 510(k) record lists Clearmind Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearPath Disposable Introducer?

The FDA product code for ClearPath Disposable Introducer is GWG.

Other records listing Clearmind Biomedical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230125Neuroblade SystemK201308Axonpen, Axonmonitor, Axonbox, Tablet

Related Devices (Code: GWG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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