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 a medical device manufactured by Clarus Medical, LLC. It received FDA 510(k) clearance on 2021-03-18 under approval 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. It is manufactured by Clarus Medical, LLC. The 510(k) number is K200925.
When was Clarus Peel-Away Introducer Sheath approved by the FDA?
Clarus Peel-Away Introducer Sheath received FDA 510(k) clearance on 2021-03-18, under approval number K200925.
What company makes Clarus Peel-Away Introducer Sheath?
Clarus Peel-Away Introducer Sheath is manufactured by Clarus Medical, LLC.
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 Devices by Clarus Medical, LLC
Related Devices (Code: GWG)
K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc.
K152699Apollo SystemPenumbra, Inc.
K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG
K171332Artemis Neuro Evacuation DevicePenumbra, Inc.
K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc.
K162880TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc.
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.