ColpoWave Colpotomizer and CerviGrip Uterine Manipulator
K-Number: K161065 · 2016-10-27
ApplicantSurgitools Pty , Ltd.
Decision Date2016-10-27
Product CodeHEW
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is a medical device manufactured by Surgitools Pty , Ltd.. It received FDA 510(k) clearance on 2016-10-27 under approval number K161065. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ColpoWave Colpotomizer and CerviGrip Uterine Manipulator?
ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is a medical device that received FDA 510(k) clearance on 2016-10-27. It is manufactured by Surgitools Pty , Ltd.. The 510(k) number is K161065.
When was ColpoWave Colpotomizer and CerviGrip Uterine Manipulator approved by the FDA?
ColpoWave Colpotomizer and CerviGrip Uterine Manipulator received FDA 510(k) clearance on 2016-10-27, under approval number K161065.
What company makes ColpoWave Colpotomizer and CerviGrip Uterine Manipulator?
ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is manufactured by Surgitools Pty , Ltd..
What is the FDA product code for ColpoWave Colpotomizer and CerviGrip Uterine Manipulator?
The FDA product code for ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is HEW.
Related Clinical Trials
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.