GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES— 510(k) K042231

Substantially Equivalent

Biocompatibles UK Limited

FDA 510(k) clearance K042231 for GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES, Substantially Equivalent on 2004-11-12. Applicant: Biocompatibles UK Limited.

Clearance details

Applicant: Biocompatibles UK Limited
Product code: Code HCG
Advisory panel: Neurology
Date received: 2004-08-17
Decision date: 2004-11-12
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.