FDA product code LOG: Catheter, Balloon For Retinal Reattachment
LOG is the FDA product code for catheter, balloon for retinal reattachment. It is a Class III device, reviewed by the Ophthalmic panel. Devices under LOG 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 | Catheter, Balloon For Retinal Reattachment |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LOG devices
openFDA lists no recalls for product code LOG.
Frequently asked questions
What is FDA product code LOG?
LOG is the FDA product code for catheter, balloon for retinal reattachment. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is LOG?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LOG
- Run a recall and safety report across every LOG manufacturer
- Watch product code LOG 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.