FDA product code JEL: Curette, Biopsy, Bronchoscope (Rigid)
JEL is the FDA product code for curette, biopsy, bronchoscope (rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under JEL. The average 510(k) review took 257 days (median 257).
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).
Classification
| Field | Value |
|---|---|
| Device name | Curette, Biopsy, Bronchoscope (Rigid) |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every JEL clearance
Top JEL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Osteo Systems, Inc. | 1 | 1994-02-22 |
Most recent JEL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932853 | Applied Osteo Systems, Inc. | PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS | 1994-02-22 | 257 |
Recalls for JEL devices
openFDA lists no recalls for product code JEL.
Frequently asked questions
What is FDA product code JEL?
JEL is the FDA product code for curette, biopsy, bronchoscope (rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is JEL?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code JEL?
Across 1 cleared submissions the average was 257 days from receipt to decision (median 257).
Which companies have the most JEL clearances?
Applied Osteo Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JEL
- Run a recall and safety report across every JEL manufacturer
- Watch product code JEL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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