Cleared Traditional

K182211 - Aurora Surgiscope System

K182211 is an FDA 510(k) clearance for Aurora Surgiscope System, manufactured by Rebound Therapeutics Corporation. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 156-day FDA review.

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

FDA 510(k) Submission Details - K182211

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.

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 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