JELClass II

Curette, Biopsy, Bronchoscope (Rigid)

21 CFR 874.4680 / Ear, Nose, Throat

JEL is the FDA product code for Curette, Biopsy, Bronchoscope (Rigid), 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 one 510(k) clearance under this code, the most recent dated 1994-02-22, and no recalls.

Classification record

Product code: JEL
Device name: Curette, Biopsy, Bronchoscope (Rigid)
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: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code JEL

By decision year

1 clearance under product code JEL with a decision year between 1994 and 1994, 1994 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code JEL by decision year
Year	Clearances
1994	1

Applicants with the most clearances

Product code JEL

Applicants holding the most 510(k) clearances under product code JEL
Applicant	Clearances
Applied Osteo Systems, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code JEL

K932853Class IIPin Holders, Transfixing Pins, Ol Wires, Half PinsApplied Osteo Systems, Inc. / cleared 1994-02-22

Recent recalls

Product code JEL

FDA records show no recalls under product code JEL.

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)