FDA product code LTA: Fluid, Hysteroscopy
LTA is the FDA product code for fluid, hysteroscopy. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under LTA reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Fluid, Hysteroscopy |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LTA devices
openFDA lists no recalls for product code LTA.
Frequently asked questions
What is FDA product code LTA?
LTA is the FDA product code for fluid, hysteroscopy. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is LTA?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LTA
- Run a recall and safety report across every LTA manufacturer
- Watch product code LTA 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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