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ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161065
510(k) Type
Traditional
Applicant
Surgitools Pty Ltd.
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
10/27/2016
Days to Decision
195 days
Submission Type
Summary

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161065
510(k) Type
Traditional
Applicant
Surgitools Pty Ltd.
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
10/27/2016
Days to Decision
195 days
Submission Type
Summary