AspireAssist
FDA premarket approval P150024/S004 · decided 2016-11-04
Approval details
- PMA number
- P150024
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AspireAssist
- Generic name
- Aspiration therapy system
- Applicant
- Aspire Bariatrics, Inc.
- Date received
- 2016-08-16
- Decision date
- 2016-11-04
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- OYF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- King Of Prussia, PA
- Statement
- Approval for a design modification to extend the length of the drain tube.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |