GELSPHERES EMBOLIC AGENT— 510(k) K023089

Substantially Equivalent

Biocure, Inc.

FDA 510(k) clearance K023089 for GELSPHERES EMBOLIC AGENT, Substantially Equivalent on 2002-12-16. Applicant: Biocure, Inc..

Clearance details

Applicant: Biocure, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2002-09-17
Decision date: 2002-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South West Ranches, FL, 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.