Cleared Special

K250752 - AURORA® Surgiscope® System (ASX15/60) (FDA 510(k) Clearance)

Also includes:
AURORA® Surgiscope® System (ASX15/80)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250752 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
28d
Days
Class 2
Risk

K250752 is an FDA 510(k) clearance for the AURORA® Surgiscope® System (ASX15/60). Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Princeton, US). The FDA issued a Cleared decision on April 9, 2025 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra LifeSciences Corporation devices

Submission Details

510(k) Number K250752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2025
Decision Date April 09, 2025
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K250752.
HJY VisualNext 3D Endoscopic Vision System
K243429 · Hjy Smart Medical Device Co., Ltd. · May 2025
cCeLL - In vivo
K233391 · VPIX Medical, Inc. · Aug 2024
QEVO System
K232159 · Carl Zeiss Meditec, AG · Sep 2023
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
K211202 · Stryker · Aug 2021