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Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212048
510(k) Type
Traditional
Applicant
Intuitive Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/26/2021
Days to Decision
57 days
Submission Type
Summary

Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212048
510(k) Type
Traditional
Applicant
Intuitive Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/26/2021
Days to Decision
57 days
Submission Type
Summary