Cleared Traditional

HD Mediastinoscope

K202272 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat

May 2021

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K202272 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 May 11, 2021, 273 days after receiving the submission on August 11, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4720.

Submission Details

510(k) Number	K202272 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2020
Decision Date	May 11, 2021
Days to Decision	273 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).