Cleared Traditional

Aurora Surgiscope System

K232618 · Rebound Therapeutics Corporation · Neurology

Oct 2023

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K232618 is an FDA 510(k) clearance for the Aurora Surgiscope System, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Rebound Therapeutics Corporation (Irvine, US). The FDA issued a Cleared decision on October 27, 2023, 59 days after receiving the submission on August 29, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K232618 FDA.gov
FDA Decision	Cleared 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

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).