Aspire Introducer Needle— 510(k) K180725

Substantially Equivalent

Aspire Bariatrics, Inc.

FDA 510(k) clearance K180725 for Aspire Introducer Needle, Substantially Equivalent on 2018-07-11. Applicant: Aspire Bariatrics, Inc..

Clearance details

Applicant: Aspire Bariatrics, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2018-03-20
Decision date: 2018-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.