Cleared Traditional

K200925 - Clarus Peel-Away Introducer Sheath

K200925 is an FDA 510(k) clearance for Clarus Peel-Away Introducer Sheath, manufactured by Clarus Medical, LLC. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K200925 · Clarus Medical, LLC · Neurology device
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Mar 2021
Decision
345d
Days
Class 2
Risk

K200925 is an FDA 510(k) clearance for the Clarus Peel-Away Introducer Sheath. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Clarus Medical, LLC (Plymouth, US). The FDA issued a Cleared decision on March 18, 2021 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clarus Medical, LLC devices

FDA 510(k) Submission Details - K200925

510(k) Number K200925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2020
Decision Date March 18, 2021
Days to Decision 345 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 148d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWG Device Classification - Class 2, Special Controls

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWG Endoscope, Neurological

All 65
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K200925.
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Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
K201840 · Rebound Therapeutics · Nov 2020
Aurora Surgiscope System
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