MEDISYSTEMS BUTTONHOLE NEEDLE SETS— 510(k) K990803

Substantially Equivalent

Medisystems Corp.

FDA 510(k) clearance K990803 for MEDISYSTEMS BUTTONHOLE NEEDLE SETS, Substantially Equivalent on 2000-01-06. Applicant: Medisystems Corp..

Clearance details

Applicant: Medisystems Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1999-03-10
Decision date: 2000-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

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.