PVA FOAM EMBOLIZATION PARTICLES— 510(k) K001678

Substantially Equivalent

Surgica Corp.

FDA 510(k) clearance K001678 for PVA FOAM EMBOLIZATION PARTICLES, Substantially Equivalent on 2001-01-25. Applicant: Surgica Corp..

Clearance details

Applicant: Surgica Corp.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2000-06-01
Decision date: 2001-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.