Aspire Introducer Needle
FDA 510(k) clearance K180725 · decided 2018-07-11
Clearance details
- K-number
- K180725
- Device name
- Aspire Introducer Needle
- Applicant
- Aspire Bariatrics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-20
- Decision date
- 2018-07-11
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- King Of Prussia, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Pathway Clinical Trial Cohort (P150024/S016) | Aspire Bariatrics, Inc. | 2020-04-24 |
| AspireAssist (P150024/S010) | Aspire Bariatrics, Inc. | 2019-01-15 |
| AspireAssist (P150024/S008) | Aspire Bariatrics, Inc. | 2018-11-09 |
| AspireAssist (P150024/S012) | Aspire Bariatrics, Inc. | 2018-10-24 |
| AspireAssist (P150024/S011) | Aspire Bariatrics, Inc. | 2018-06-19 |
| AspireAssist (P150024/S009) | Aspire Bariatrics, Inc. | 2018-02-23 |
| Aspire Assist (P150024/S006) | Aspire Bariatrics, Inc. | 2017-07-17 |
| AspireAssist (P150024/S005) | Aspire Bariatrics, Inc. | 2016-12-15 |