Cleared Traditional

HD Mediastinoscope

K213194 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat

Jun 2022

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K213194 is an FDA 510(k) clearance for the HD Mediastinoscope, a Mediastinoscope, Surgical (Class II — Special Controls, product code EWY), submitted by KARL STORZ Endoscopy-America, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 23, 2022, 267 days after receiving the submission on September 29, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4720.

Submission Details

510(k) Number	K213194 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2021
Decision Date	June 23, 2022
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EWY — Mediastinoscope, Surgical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4720
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).