DeviceClearance

Product code JEJ— Ear, Nose, Throat

EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019

Classification name
Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Total cleared
2
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 JEJ under 21 CFR 874.4680, via openFDA

Market context for product code JEJ

FDA has cleared 2 devices under product code JEJ between 1982 and 1987, filed by 2 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 JEJ

Recent clearances under product code JEJ

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