Medical Device Manufacturer · US , San Jose , CA

Ximed/Prosure/Injectx - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1995

Recent clearances: PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES, INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX, INJECTION NEEDLE PROBE/DEVICE-TUNIS

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ximed/Prosure/Injectx Gastroenterology & Urology ✕

3 devices

1-3 of 3

Cleared Dec 11, 1998

INJECTION NEEDLE PROBE/DEVICE-TUNIS

Gastroenterology & Urology · 46d

Cleared May 12, 1998

ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE

Gastroenterology & Urology · 40d

Cleared Jan 07, 1998

ELECTRODES/PROBES/DEVICES

Gastroenterology & Urology · 26d