Steripath Gen2 Blood Collection System— 510(k) K192247

Substantially Equivalent

Magnolia Medical Technologies, Inc.

FDA 510(k) clearance K192247 for Steripath Gen2 Blood Collection System, Substantially Equivalent on 2020-02-28. Applicant: Magnolia Medical Technologies, Inc..

Clearance details

Applicant: Magnolia Medical Technologies, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2019-08-19
Decision date: 2020-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.