Cleared Traditional

QEVO System with KINEVO 900

K170667 · Carl Zeiss Meditec, AG · Neurology

Aug 2017

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K170667 is an FDA 510(k) clearance for the QEVO System with KINEVO 900, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on August 18, 2017, 165 days after receiving the submission on March 6, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K170667 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2017
Decision Date	August 18, 2017
Days to Decision	165 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).