JEJClass II

Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)

21 CFR 874.4680 / Ear, Nose, Throat

JEJ is the FDA product code for Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating), a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1987-12-22, and no recalls.

Classification record

Product code: JEJ
Device name: Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
FDA 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).
Regulation: 21 CFR 874.4680
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code JEJ

By decision year

2 clearances under product code JEJ with a decision year between 1982 and 1987, 1982 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code JEJ by decision year
Year	Clearances
1982	1
1987	1

Applicants with the most clearances

Product code JEJ

Applicants holding the most 510(k) clearances under product code JEJ
Applicant	Clearances
Em Diagnostic Systems, Inc.	1
Technicon Instruments Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JEJ.

Recent clearances

Product code JEJ

Recent recalls

Product code JEJ

FDA records show no recalls under product code JEJ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)