FDA product code OGO: Intraocular Pressure Lowering Implant
OGO is the FDA product code for intraocular pressure lowering implant. It is a Class III device, reviewed by the Ophthalmic panel. Devices under OGO reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 4 recalls for OGO devices.
Definition
An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.
Classification
| Field | Value |
|---|---|
| Device name | Intraocular Pressure Lowering Implant |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OGO devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-28.
| Year | Recalls |
|---|---|
| 2018 | 4 |
Frequently asked questions
What is FDA product code OGO?
OGO is the FDA product code for intraocular pressure lowering implant. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is OGO?
Class III. Typical premarket route: PMA.
Have OGO devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2018-08-28.
Next steps
- Run an FDA pathway report with predicate devices for product code OGO
- Run a recall and safety report across every OGO manufacturer
- Watch product code OGO 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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