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FDA 510(k)

SIRIUS Endoscope System (PR-SI-1230)

K-Number: K250939 · 2025-08-29

ApplicantPrecision Robotics (Hong Kong) Limited
Decision Date2025-08-29
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SIRIUS Endoscope System (PR-SI-1230) is a medical device manufactured by Precision Robotics (Hong Kong) Limited. It received FDA 510(k) clearance on 2025-08-29 under approval number K250939. 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 (PR-SI-1230)?

SIRIUS Endoscope System (PR-SI-1230) is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by Precision Robotics (Hong Kong) Limited. The 510(k) number is K250939.

When was SIRIUS Endoscope System (PR-SI-1230) approved by the FDA?

SIRIUS Endoscope System (PR-SI-1230) received FDA 510(k) clearance on 2025-08-29, under approval number K250939.

What company makes SIRIUS Endoscope System (PR-SI-1230)?

SIRIUS Endoscope System (PR-SI-1230) is manufactured by Precision Robotics (Hong Kong) Limited.

What is the FDA product code for SIRIUS Endoscope System (PR-SI-1230)?

The FDA product code for SIRIUS Endoscope System (PR-SI-1230) 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

K221642SIRIUS Endoscope System

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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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