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Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231872
510(k) Type
Traditional
Applicant
Kirwan Surgical Products LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/2023
Days to Decision
60 days
Submission Type
Summary

Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231872
510(k) Type
Traditional
Applicant
Kirwan Surgical Products LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/2023
Days to Decision
60 days
Submission Type
Summary