ENZ — Telescope, Laryngeal-Bronchial Class II

FDA Device Classification

Classification Details

Product Code: ENZ
Device Class: Class II
Regulation Number: 874.4680
Submission Type
Review Panel: EN
Medical Specialty: Ear, Nose, Throat
Implant: No

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).

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K944032	jedmed instrument	VIDEO SCOPE SYSTEM (LARYNGOSCOPE)	September 15, 1995
K943904	karl storz endoskop	RIGID TELESCOPES	October 14, 1994
K790845	national medical technology	DUALUME LARYNGEAL EXAMINATION TELESCOPE	July 24, 1979