LTI · Implant, Intragastric For Morbid Obesity
· Class 3
Overview
| Product Code | LTI |
|---|---|
| Device Name | Implant, Intragastric For Morbid Obesity |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250023 | Allurion Gastric Balloon System | Allurion Technologies, Inc. | Feb 20, 2026 | APPR |
| P190012 | Spatz3 Adjustable Balloon System | Spatz Fgia, Inc. | Oct 15, 2021 | APPR |
| P180024 | TransPyloric Shuttle/TransPyloric Shuttle Delivery Device | Baronova, Inc. | Apr 16, 2019 | APPR |
| P160001 | OBALON BALLOON SYSTEM | Medtimo, Inc. | Sep 8, 2016 | APPR |
| P140008 | ORBERA INTRAGASTRIC BALLOON | Boston Scientific Corporation | Aug 5, 2015 | APPR |
| P140012 | RESHAPE INTEGRATED DUAL BALLOON SYSTEM | Boston Scientific Corporation | Jul 28, 2015 | APWD |
| P070009 | REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X | Obtech Medical GmbH | Sep 28, 2007 | APWD |
| P000008 | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM | Medtimo, Inc. | Jun 5, 2001 | APPR |
Top Applicants
- Boston Scientific Corporation — 2 clearances
- Medtimo, Inc. — 2 clearances
- Allurion Technologies, Inc. — 1 clearance
- Baronova, Inc. — 1 clearance
- Obtech Medical GmbH — 1 clearance
