HEAD FIXATION ARC AND TABLE BASE— 510(k) K091439

Substantially Equivalent

Surgivision, Inc.

FDA 510(k) clearance K091439 for HEAD FIXATION ARC AND TABLE BASE, Substantially Equivalent on 2009-08-25. Applicant: Surgivision, Inc..

Clearance details

Applicant: Surgivision, Inc.
Product code: Code HBL
Advisory panel: Neurology
Date received: 2009-05-14
Decision date: 2009-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.