Amia Automated PD System with Sharesource— 510(k) K151525

Substantially Equivalent

Deka Research and Development

FDA 510(k) clearance K151525 for Amia Automated PD System with Sharesource, Substantially Equivalent on 2015-10-09. Applicant: Deka Research and Development.

Clearance details

Applicant: Deka Research and Development
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 2015-06-08
Decision date: 2015-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.