MEDISYSTEMS FISTULA NEEDLE— 510(k) K811838

Substantially Equivalent

Medisystems Corp.

FDA 510(k) clearance K811838 for MEDISYSTEMS FISTULA NEEDLE, Substantially Equivalent on 1981-09-08. Applicant: Medisystems Corp..

Clearance details

Applicant: Medisystems Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1981-07-01
Decision date: 1981-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.