BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM— 510(k) K030578

Substantially Equivalent

Computer Motion, Inc.

FDA 510(k) clearance K030578 for BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM, Substantially Equivalent on 2003-06-24. Applicant: Computer Motion, Inc..

Clearance details

Applicant: Computer Motion, Inc.
Product code: Code NAY
Advisory panel: Gastroenterology, Urology
Date received: 2003-02-24
Decision date: 2003-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

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Adverse events under product code NAY

product code NAY

Death: 433
Injury: 7,927
Malfunction: 93,790
Other: 19
Total: 102,169

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.