FDA product code JEI: Claw, Foreign Body, Bronchoscope (Non-Rigid)
JEI is the FDA product code for claw, foreign body, bronchoscope (non-rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. Devices under JEI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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 | Claw, Foreign Body, Bronchoscope (Non-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) |
| Third-party 510(k) review eligible | Yes |
Recalls for JEI devices
openFDA lists no recalls for product code JEI.
Frequently asked questions
What is FDA product code JEI?
JEI is the FDA product code for claw, foreign body, bronchoscope (non-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 JEI?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JEI
- Run a recall and safety report across every JEI manufacturer
- Watch product code JEI 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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