MICROSPEED UNI MOTOR SYSTEM— 510(k) K053526

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K053526 for MICROSPEED UNI MOTOR SYSTEM, Substantially Equivalent on 2006-01-18. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code HBC
Advisory panel: Neurology
Date received: 2005-12-19
Decision date: 2006-01-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

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Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.