DeviceClearance

Product code EWY— Ear, Nose, Throat

HD Mediastinoscope

Classification name
Mediastinoscope, Surgical
Device class
Class 2
Regulation
21 CFR 874.4720
Advisory panel
Ear, Nose, Throat
Total cleared
11
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code EWY under 21 CFR 874.4720, via openFDA

Market context for product code EWY

FDA has cleared 11 devices under product code EWY between 1991 and 2026, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code EWY

Recent clearances under product code EWY

Data sourced from openFDA. This site is unofficial and independent of the FDA.