Medical Device Manufacturer · US , Cincinnati , OH

Gynetech Pty. , Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gynetech Pty. , Ltd. Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Aug 19, 2015

ManipulatOR PRO, ManipulatOR

Obstetrics & Gynecology · 170d

Cleared Dec 19, 2014

InsufflatOR Needle

Obstetrics & Gynecology · 88d

Cleared Dec 17, 2014

Obstetrics & Gynecology · 133d

Cleared Sep 02, 2005

MCCARTNEY ACCESS TUBE

Obstetrics & Gynecology · 78d