KLZ — Tube, Shunt, Endolymphatic With Valve Class II

FDA Device Classification

FDA product code KLZ covers "Tube, Shunt, Endolymphatic With Valve", a Class II medical device regulated under 21 CFR 874.3850. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
KLZ
Device Class
Class II
Regulation Number
874.3850
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K972383a.stein - regulatory affairs consultingEASY-JET DEVICENovember 23, 1999