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FDA 510(k)

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

K-Number: K250752 · 2025-04-09

ApplicantIntegra LifeSciences Corporation
Decision Date2025-04-09
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2025-04-09 under approval number K250752. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)?

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) is a medical device that received FDA 510(k) clearance on 2025-04-09. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K250752.

When was AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) approved by the FDA?

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) received FDA 510(k) clearance on 2025-04-09, under approval number K250752.

What company makes AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)?

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)?

The FDA product code for AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) is GWG.

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Related Devices (Code: GWG)

K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. K152699Apollo SystemPenumbra, Inc. K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG K171332Artemis Neuro Evacuation DevicePenumbra, Inc. K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. K162880TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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