FDA product code LBP: Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
LBP is the FDA product code for replacement, ossicular (stapes) using absorbable gelatin material. It is a Class II device, regulated under 21 CFR 874.3450 and reviewed by the Ear, Nose and Throat panel. Devices under LBP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material |
| Device class | Class II |
| Regulation | 21 CFR 874.3450 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for LBP devices
openFDA lists no recalls for product code LBP.
Frequently asked questions
What is FDA product code LBP?
LBP is the FDA product code for replacement, ossicular (stapes) using absorbable gelatin material. It is a Class II device, regulated under 21 CFR 874.3450 and reviewed by the Ear, Nose and Throat panel.
What device class is LBP?
Class II, regulation 21 CFR 874.3450. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LBP
- Run a recall and safety report across every LBP manufacturer
- Watch product code LBP 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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