FDA product code LRE: Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
LRE is the FDA product code for instrument, prosthesis modification for ossicular replacement surgery, sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel. Devices under LRE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 874.3540 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for LRE devices
openFDA lists no recalls for product code LRE.
Frequently asked questions
What is FDA product code LRE?
LRE is the FDA product code for instrument, prosthesis modification for ossicular replacement surgery, sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel.
What device class is LRE?
Class I, regulation 21 CFR 874.3540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code LRE
- Run a recall and safety report across every LRE manufacturer
- Watch product code LRE 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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