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510(k) K250939

SIRIUS Endoscope System (PR-SI-1230) by Precision Robotics (Hong Kong) Limited — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2025
Date Received
March 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Precision Robotics (Hong Kong) Limited

  • K221642 — SIRIUS Endoscope System (December 12, 2022)

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  • K190190 — WV1 Endoscope (November 1, 2019)
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