Steripath Micro Blood Collection System— 510(k) K200661

Substantially Equivalent

Magnolia Medical Technologies, Inc.

FDA 510(k) clearance K200661 for Steripath Micro Blood Collection System, Substantially Equivalent on 2020-10-08. Applicant: Magnolia Medical Technologies, Inc..

Clearance details

Applicant: Magnolia Medical Technologies, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2020-03-12
Decision date: 2020-10-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.