Cleared Traditional

Clarus Peel-Away Introducer Sheath (K200925) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 45
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K200925.
HJY VisualNext Endoscopic Vision System
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1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
K211202 · Stryker · Aug 2021
ClearPath Disposable Introducer
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Axonpen, Axonmonitor, Axonbox, Tablet
K201308 · Clearmind Biomedical · Nov 2020
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
K201840 · Rebound Therapeutics · Nov 2020
Aurora Surgiscope System
K191861 · Rebound Therapeutics · Dec 2019