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

Name: FDA 510(k) clearance K161065
Creator: U.S. Food and Drug Administration
Published: 2016-10-27

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.. Device class: 2.

Clearance details

Applicant: Surgitools Pty , Ltd.
Product code: Code HEW
Device class: Class 2
Regulation: 21 CFR 884.1640
Advisory panel: Obstetrics/Gynecology
Date received: 2016-04-15
Decision date: 2016-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodvale, AU

Download summary PDF View on FDA.gov ↗

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