JMS APHERESIS NEEDLE— 510(k) K880726

Substantially Equivalent

Jms Co., Ltd.

FDA 510(k) clearance K880726 for JMS APHERESIS NEEDLE, Substantially Equivalent on 1988-03-16. Applicant: Jms Co., Ltd..

Clearance details

Applicant: Jms Co., Ltd.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1988-02-23
Decision date: 1988-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hiroshima, JP

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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.