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StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142432
510(k) Type
Traditional
Applicant
BIONESS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/20/2015
Days to Decision
175 days
Submission Type
Statement

StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142432
510(k) Type
Traditional
Applicant
BIONESS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/20/2015
Days to Decision
175 days
Submission Type
Statement