FDA product code LOB: Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
LOB is the FDA product code for dilator, cervical, synthetic, osmotic, pregnancy termination. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under LOB reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 4 recalls for LOB devices.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LOB devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 3 still open. Most recent: 2020-06-03.
| Year | Recalls |
|---|---|
| 2019 | 3 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code LOB?
LOB is the FDA product code for dilator, cervical, synthetic, osmotic, pregnancy termination. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is LOB?
Class III. Typical premarket route: PMA.
Have LOB devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2020-06-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LOB
- Run a recall and safety report across every LOB manufacturer
- Watch product code LOB 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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