Cleared Special

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

K250752 · Integra LifeSciences Corporation · Neurology

Apr 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K250752 is an FDA 510(k) clearance for the AURORA? Surgiscope? System (ASX15/60); AURORA? Surgiscope? System (ASX15/80), a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Integra LifeSciences Corporation (Princeton, US). The FDA issued a Cleared decision on April 9, 2025, 28 days after receiving the submission on March 12, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K250752 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	GWG — Endoscope, Neurological
Device Class	Class II — 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).