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FDA 510(k)

Clarus Peel-Away Introducer Sheath

K-Number: K200925 · 2021-03-18

ApplicantClarus Medical, LLC
Decision Date2021-03-18
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Clarus Peel-Away Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical, LLC. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K200925. 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 Clarus Peel-Away Introducer Sheath?

Clarus Peel-Away Introducer Sheath is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Clarus Medical, LLC. The 510(k) number is K200925.

When did Clarus Peel-Away Introducer Sheath receive FDA 510(k) clearance?

Clarus Peel-Away Introducer Sheath received FDA 510(k) clearance on 2021-03-18, under 510(k) number K200925.

Who is the listed applicant for Clarus Peel-Away Introducer Sheath?

The FDA 510(k) record lists Clarus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clarus Peel-Away Introducer Sheath?

The FDA product code for Clarus Peel-Away Introducer Sheath is GWG.

Other records listing Clarus Medical, LLC 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.

K252790Digital ClarusScope System and Digital NeuroPEN SystemK240535Digital ClarusScope System; Digital NeuroPEN SystemK223615Digital ClarusScope System, Digital NeuroPEN System

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.

K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro Irrigation SystemStryker InstrumentsK243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences CorporationK233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

Official Source

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

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