ColpoWave Colpotomizer and CerviGrip Uterine Manipulator— 510(k) K161065

Substantially Equivalent

Surgitools Pty , Ltd.

FDA 510(k) clearance K161065 for ColpoWave Colpotomizer and CerviGrip Uterine Manipulator, Substantially Equivalent on 2016-10-27. Applicant: Surgitools Pty , Ltd..

Clearance details

Applicant: Surgitools Pty , Ltd.
Product code: Code HEW
Advisory panel: Obstetrics/Gynecology
Date received: 2016-04-15
Decision date: 2016-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodvale, AU

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Data sourced from openFDA. This site is unofficial and independent of the FDA.