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510(k) K221642

SIRIUS Endoscope System by Precision Robotics (Hong Kong) Limited — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2022
Date Received
June 6, 2022
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

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