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FDA 510(k)

SIRIUS Endoscope System

K-Number: K221642 · 2022-12-12

ApplicantPrecision Robotics (Hong Kong) Limited
Decision Date2022-12-12
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SIRIUS Endoscope System is a medical device manufactured by Precision Robotics (Hong Kong) Limited. It received FDA 510(k) clearance on 2022-12-12 under approval number K221642. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRIUS Endoscope System?

SIRIUS Endoscope System is a medical device that received FDA 510(k) clearance on 2022-12-12. It is manufactured by Precision Robotics (Hong Kong) Limited. The 510(k) number is K221642.

When was SIRIUS Endoscope System approved by the FDA?

SIRIUS Endoscope System received FDA 510(k) clearance on 2022-12-12, under approval number K221642.

What company makes SIRIUS Endoscope System?

SIRIUS Endoscope System is manufactured by Precision Robotics (Hong Kong) Limited.

What is the FDA product code for SIRIUS Endoscope System?

The FDA product code for SIRIUS Endoscope System is HET.

Related Clinical Trials

NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING

Other Devices by Precision Robotics (Hong Kong) Limited

K250939SIRIUS Endoscope System (PR-SI-1230)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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