Cleared Traditional

Aurora Surgiscope System (K182211) - FDA 510(k) Clearance

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

K182211 · Rebound Therapeutics Corporation · Neurology device
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Jan 2019
Decision
156d
Days
Class 2
Risk

K182211 is an FDA 510(k) clearance for the Aurora Surgiscope System. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Rebound Therapeutics Corporation (Irvine, US). The FDA issued a Cleared decision on January 18, 2019 after a review of 156 days - an extended review cycle.

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. Standard predicate reliance. 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 Rebound Therapeutics Corporation devices

Submission Details

510(k) Number K182211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2018
Decision Date January 18, 2019
Days to Decision 156 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
8d slower than avg
Panel avg: 148d · This submission: 156d
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 K182211.
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
K201840 · Rebound Therapeutics · Nov 2020
Aurora Surgiscope System
K191861 · Rebound Therapeutics · Dec 2019
Artemis Eye System
K190719 · Penumbra, Inc. · Aug 2019
MR Compatible Aspiration Kit
K181731 · Mri Interventions, Inc. · Nov 2018
CONVIVO
K181116 · Carl Zeiss Meditec, AG · Oct 2018
Cellvizio 100 Series Systems with Confocal Miniprobes
K180270 · Mauna Kea Technologies · May 2018