# LTI · Implant, Intragastric For Morbid Obesity

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/LTI

## Overview

- **Product Code:** LTI
- **Device Name:** Implant, Intragastric For Morbid Obesity
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250023](/device/P250023.md) | Allurion™ Gastric Balloon System | Allurion Technologies, Inc. | Feb 20, 2026 | APPR |
| [P190012](/device/P190012.md) | Spatz3 Adjustable Balloon System | Spatz Fgia, Inc. | Oct 15, 2021 | APPR |
| [P180024](/device/P180024.md) | TransPyloric Shuttle/TransPyloric Shuttle Delivery Device | Baronova, Inc. | Apr 16, 2019 | APPR |
| [P160001](/device/P160001.md) | OBALON BALLOON SYSTEM | Medtimo, Inc. | Sep 8, 2016 | APPR |
| [P140008](/device/P140008.md) | ORBERA INTRAGASTRIC BALLOON | Boston Scientific Corporation | Aug 5, 2015 | APPR |
| [P140012](/device/P140012.md) | RESHAPE INTEGRATED DUAL BALLOON SYSTEM | Boston Scientific Corporation | Jul 28, 2015 | APWD |
| [P070009](/device/P070009.md) | REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X | Obtech Medical GmbH | Sep 28, 2007 | APWD |
| [P000008](/device/P000008.md) | 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

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**Source:** [https://fda.innolitics.com/productcode/LTI](https://fda.innolitics.com/productcode/LTI)

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