AspireAssist
FDA premarket approval P150024/S012 · decided 2018-10-24
Approval details
- PMA number
- P150024
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AspireAssist
- Generic name
- Aspiration therapy system
- Applicant
- Aspire Bariatrics, Inc.
- Date received
- 2018-09-25
- Decision date
- 2018-10-24
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OYF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- King Of Prussia, PA
- Statement
- Approval for changes to the Physician Guide and Patient Guide.
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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 |