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da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214095
510(k) Type
Traditional
Applicant
Intuitive Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/15/2022
Days to Decision
230 days
Submission Type
Summary

da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214095
510(k) Type
Traditional
Applicant
Intuitive Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/15/2022
Days to Decision
230 days
Submission Type
Summary