Cleared Special

QEVO System

K232159 · Carl Zeiss Meditec, AG · Neurology

Sep 2023

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K232159 is an FDA 510(k) clearance for the QEVO System, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Carl Zeiss Meditec, AG (Oberkochen, DE). The FDA issued a Cleared decision on September 21, 2023, 63 days after receiving the submission on July 20, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K232159 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 2023
Decision Date	September 21, 2023
Days to Decision	63 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).