AspireAssist Aspiration Therapy System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- AspireAssist FDA PMA
- Generic Name
- Aspiration therapy system FDA PMA
Identifiers
- PMA Number
- P150024 FDA PMA
- FDA Product Code
- OYF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APWD FDA PMA
The AspireAssist is an aspiration therapy system designed to assist in weight reduction of obese patients. It is indicated for use in adults aged 22 or older with a Body Mass Index (BMI) of 35.0-55.0 kg/m2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy.
The device is intended for long-term use in conjunction with lifestyle therapy and continuous medical monitoring. It is supplied as a Class III medical device with FDA PMA approval, manufactured by Aspire Bariatrics, Inc. in King Of Prussia, PA.
Frequently asked questions
What is the AspireAssist device used for?
The AspireAssist is an aspiration therapy system designed to assist in weight reduction of obese patients. It is indicated for adults aged 22 or older with a BMI of 35.0-55.0 kg/m2 who have failed to achieve weight loss with non-surgical methods.
How is the AspireAssist device supplied?
The AspireAssist is supplied as a Class III medical device manufactured by Aspire Bariatrics, Inc. in King Of Prussia, PA. It is intended for long-term use in conjunction with lifestyle therapy and continuous medical monitoring.
Is the AspireAssist device reusable or single-use?
The device information does not specify whether the AspireAssist is reusable or single-use. The device is intended for long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.
What are the storage requirements for the AspireAssist?
The device data does not provide specific storage requirements for the AspireAssist. As a Class III medical device, it should be stored according to the manufacturer's instructions to maintain its integrity and functionality.
What is the regulatory route for the AspireAssist?
The AspireAssist has FDA PMA approval (PMA number: P150024) and is classified as a Class III medical device. It received FDA approval on June 14, 2016, for use in weight reduction of obese patients.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150024 | Class III | Active |
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Manufacturer
- Manufacturer
- Aspire Bariatrics, Inc.
Sources (1)
- FDA PMA P150024 24 fields · synced Sep 18, 2026