510(k) K212835— AquaBeam Robotic System

Substantially Equivalent

Procept Biorobotics, Corporation

Clearance details

Applicant: Procept Biorobotics, Corporation
Product code: Code PZP
Advisory panel: General, Plastic Surgery
Date received: 2021-09-07
Decision date: 2021-10-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

Adverse events under product code PZP

product code PZP

Death: 28
Injury: 622
Malfunction: 627
Total: 1,277

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.