Medical Device Manufacturer · GB , England

Gyrus Medical , Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1990

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gyrus Medical , Ltd. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Dec 19, 2000

PLASMAKINETIC ENDOUROLOGY SYSTEM

Gastroenterology & Urology · 29d

Cleared Apr 28, 2000

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

Gastroenterology & Urology · 8d

Cleared Dec 27, 1999

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE

Gastroenterology & Urology · 18d

Cleared Jun 29, 1999

GYRUS ENDOUROLOGY SYSTEM

Gastroenterology & Urology · 124d