EWYClass II

Mediastinoscope, Surgical

21 CFR 874.4720 / Ear, Nose, Throat

EWY is the FDA product code for Mediastinoscope, Surgical, a class II device type, regulated under 21 CFR 874.4720. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 2026-03-02, and no recalls.

Classification record

Product code: EWY
Device name: Mediastinoscope, Surgical
FDA 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).
Regulation: 21 CFR 874.4720
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 11
Ingested recalls: 0

Clearances, product code EWY

By decision year

11 clearances under product code EWY with a decision year between 1991 and 2026, 1991 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code EWY by decision year
Year	Clearances
1991	2
1993	1
1995	1
1997	1
2015	1
2016	1
2017	1
2021	1
2022	1
2026	1

Applicants with the most clearances

Product code EWY

Applicants holding the most 510(k) clearances under product code EWY
Applicant	Clearances
Karl Storz Endoscopy-America, Inc.	3
Olympus Corp.	3
Aegis Surgical, Ltd.	2
Boston-Biomedical Associates	1
Karl Storz SE & Co. KG	1
Richard Wolf Medical Instruments Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order