SURGITA/MIZHO MICRONEUROSURGERY HEAD FR— 510(k) K821772

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K821772 for SURGITA/MIZHO MICRONEUROSURGERY HEAD FR, Substantially Equivalent on 1982-09-28. Applicant: Downs Surgical , Ltd..

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code HBL
Advisory panel: Neurology
Date received: 1982-06-16
Decision date: 1982-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.