AspireAssist
FDA premarket approval P150024 · decided 2016-06-14
Approval details
- PMA number
- P150024
- Trade name
- AspireAssist
- Generic name
- Aspiration therapy system
- Applicant
- Aspire Bariatrics, Inc.
- Date received
- 2015-07-08
- Decision date
- 2016-06-14
- Days to decision
- 342 days
- Decision code
- APWD
- Product code
- OYF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- King Of Prussia, PA
- Statement
- Approval for the AspireAssist® is intended 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 AspireAssist is intended for a long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Aspire Venting Tube (K182248) | Aspire Bariatrics, Inc. | 2018-11-13 |
| Aspire Introducer Needle (K180725) | Aspire Bariatrics, Inc. | 2018-07-11 |