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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 the device name listed in this FDA 510(k) record. The listed applicant is Precision Robotics (Hong Kong) Limited. It received FDA 510(k) clearance on 2025-08-29 under 510(k) 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. The listed applicant is Precision Robotics (Hong Kong) Limited. The 510(k) number is K250939.

When did SIRIUS Endoscope System (PR-SI-1230) receive FDA 510(k) clearance?

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

Who is the listed applicant for SIRIUS Endoscope System (PR-SI-1230)?

The FDA 510(k) record lists Precision Robotics (Hong Kong) Limited as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Precision Robotics (Hong Kong) Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221642SIRIUS Endoscope System

Related Devices (Code: HET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))Schoelly Fiberoptic GmbH

Official Source

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

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