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 General & Plastic Surgery ✕

13 devices

1-13 of 13

Cleared Mar 01, 1999

FIXATION SYSTEM

General & Plastic Surgery · 161d

Cleared Jan 16, 1998

SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON...

General & Plastic Surgery · 154d

Cleared Nov 14, 1997

SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER

General & Plastic Surgery · 162d

Cleared Feb 19, 1997

SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH...

General & Plastic Surgery · 222d

Cleared Sep 23, 1996

General & Plastic Surgery · 168d

Cleared Aug 07, 1995

THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA

General & Plastic Surgery · 84d

Cleared Jun 29, 1995

SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA

General & Plastic Surgery · 84d

Cleared Nov 01, 1994

THE SPACEMAKER AND THE SPACEMAKER II

General & Plastic Surgery · 54d

Cleared Oct 05, 1994

General & Plastic Surgery · 20d

Cleared Aug 09, 1994

GSI CANNULA REDUCER ACCESSORY

General & Plastic Surgery · 14d

Cleared Jul 07, 1994

SPECIMEN REMOVAL DEVICE

General & Plastic Surgery · 114d

Cleared Feb 22, 1994

SURGICAL PATCH SPREADER

General & Plastic Surgery · 337d

Cleared Jun 25, 1993

SURGICAL DISSECTOR WITH CANNULA

General & Plastic Surgery · 210d