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SIRIUS Endoscope System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221642
510(k) Type
Traditional
Applicant
Precision Robotics (Hong Kong) Limited
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/12/2022
Days to Decision
189 days
Submission Type
Summary

SIRIUS Endoscope System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221642
510(k) Type
Traditional
Applicant
Precision Robotics (Hong Kong) Limited
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/12/2022
Days to Decision
189 days
Submission Type
Summary