FDA product code LTI: Implant, Intragastric For Morbid Obesity
LTI is the FDA product code for implant, intragastric for morbid obesity. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under LTI reach the market by PMA; FDA lists no cleared 510(k)s for it. 9 PMA applications cite this product code. FDA has posted 26 recalls for LTI devices.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Intragastric For Morbid Obesity |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LTI devices
26 product recalls in 9 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-05-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code LTI?
LTI is the FDA product code for implant, intragastric for morbid obesity. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is LTI?
Class III. Typical premarket route: PMA.
Have LTI devices been recalled?
Yes: 26 product recalls across 9 recall events; the most recent began 2019-05-23.
Next steps
- Run an FDA pathway report with predicate devices for product code LTI
- Run a recall and safety report across every LTI manufacturer
- Watch product code LTI 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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