EZM — Dilator, Esophageal (Metal Olive) Gastro-Urology Class II

FDA Device Classification

FDA product code EZM covers "Dilator, Esophageal (Metal Olive) Gastro-Urology", a Class II medical device regulated under 21 CFR 876.5365. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
EZM
Device Class
Class II
Regulation Number
876.5365
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No