Medical Device Manufacturer · US , Portola Valley , CA

General Surgical Innovations - FDA 510(k) Cleared Devices

14 submissions · 13 cleared · Since 1993

Recent clearances: FIXATION SYSTEM, SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK, SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER

View 14 510(k) Devices ↓

14

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - General Surgical Innovations Cardiovascular ✕

1 devices

1-1 of 1

Cleared Apr 21, 1997

GSI CANNULA WITH INTRODUCER

Cardiovascular · 90d