FDW

Esophagoscope, Rigid, Gastro-Urology

Product code: FDW
Device name: Esophagoscope, Rigid, Gastro-Urology
Device class: Class 2
21 CFR: 21 CFR 876.1500
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: FDW

Classification and pathway per current FDA publications. Data from openFDA (CC0).