Cleared Traditional

K232618 - Aurora Surgiscope System (FDA 510(k) Clearance)

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

K232618 · Rebound Therapeutics Corporation · Neurology device
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Oct 2023
Decision
59d
Days
Class 2
Risk

K232618 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 October 27, 2023 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rebound Therapeutics Corporation devices

Submission Details

510(k) Number K232618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2023
Decision Date October 27, 2023
Days to Decision 59 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
89d faster than avg
Panel avg: 148d · This submission: 59d
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 90
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K232618.
HJY VisualNext 3D Endoscopic Vision System
K243429 · Hjy Smart Medical Device Co., Ltd. · May 2025
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K233391 · VPIX Medical, Inc. · Aug 2024
Digital ClarusScope System, Digital NeuroPEN System
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K232159 · Carl Zeiss Meditec, AG · Sep 2023