ManipulatOR PRO, ManipulatOR

FDA 510(k) K150519 · Gynetech Pty. , Ltd.

Substantially Equivalent

510(k) numberK150519

Submission

Device name
ManipulatOR PRO, ManipulatOR
Applicant
Gynetech Pty. , Ltd.
Richmond, AU
Received
March 2, 2015
Decision date
August 19, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LKF – Cannula, Manipulator/Injector, Uterine
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

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Questions and answers

When was ManipulatOR PRO, ManipulatOR cleared by the FDA?

ManipulatOR PRO, ManipulatOR (K150519) received a 510(k) decision of Substantially Equivalent on August 19, 2015, 170 days after the submission was received.

What is the product code of K150519?

The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.