Obalon Touch Inflation System
PMA P160001
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP160001 | Date8 Sep 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Obalon Balloon System
- Generic Name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- PMA Number
- FDA Product Code
- LTI
- Device Class
- Class III
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Obalon Touch Inflation System is a swallowable intragastric balloon designed for temporary placement in the stomach to aid weight loss in adults with obesity (BMI 30–40 kg/m²). Classified as an implant for morbid obesity, it functions as an adjunct to dietary and behavioral weight management programs, intended for use up to six months.
The system is supplied as a single-use device and requires FDA PMA authorization (P160001). It is administered via oral ingestion, with balloons removed within six months of initial placement. No MRI safety data or reusable components are specified, and storage conditions are not detailed in the regulatory submission.
Other devices from Medtimo, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Obalon Touch Inflation System intended for and who is it designed for?
The Obalon Touch Inflation System is a swallowable intragastric balloon designed as an adjunct to dietary and behavioral weight management programs. It is intended for temporary placement in the stomach to aid weight loss in adults with obesity, specifically those with a BMI between 30 and 40 kg/m², who have not successfully lost weight through diet and exercise alone. It is meant to be used for up to six months.
Is the Obalon Touch Inflation System reusable or single-use, and how is it administered?
The Obalon Touch Inflation System is a single-use device. It is administered via oral ingestion, meaning the patient swallows the balloon, which is then inflated inside the stomach to create a sense of fullness and aid weight loss.
What regulatory pathway was followed for the Obalon Touch Inflation System, and what does this mean for its use?
The Obalon Touch Inflation System follows the FDA Pre-Market Approval (PMA) pathway, authorized under PMA number P160001. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use as described in the approval, which is temporary weight loss assistance in adults with obesity (BMI 30–40 kg/m²) as part of a structured weight management program.
How long is the Obalon Touch Inflation System intended to remain in the stomach, and what happens after that period?
The Obalon Touch Inflation System is designed for temporary use and must be removed within six months of initial placement. After this period, all balloons must be removed to ensure patient safety and proper follow-up care.
Are there any specific storage instructions provided for the Obalon Touch Inflation System?
The regulatory submission for the Obalon Touch Inflation System does not specify storage conditions. For proper handling, it is recommended to follow general medical device storage guidelines, such as keeping the device in a clean, dry environment away from direct sunlight and extreme temperatures until use.