SIRIUS Endoscope System— 510(k) K221642

Substantially Equivalent

Precision Robotics (Hong Kong) Limited

FDA 510(k) clearance K221642 for SIRIUS Endoscope System, Substantially Equivalent on 2022-12-12. Applicant: Precision Robotics (Hong Kong) Limited.

Clearance details

Applicant: Precision Robotics (Hong Kong) Limited
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2022-06-06
Decision date: 2022-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.