Company ยท US
General Surgical Innovations
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1999. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 1999 | K983318 | FIXATION SYSTEM General Surgical Innovations | GDW |
| Jan 16, 1998 | K973046 | SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK General Surgical Innovations | GCJ |
| Nov 14, 1997 | K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER General Surgical Innovations | FZW |
| Apr 21, 1997 | K970201 | GSI CANNULA WITH INTRODUCER General Surgical Innovations | DYB |
| Feb 19, 1997 | K962702 | SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA General Surgical Innovations | GCJ |
| Sep 23, 1996 | K961356 | MAMMARY SIZER General Surgical Innovations | MRD |
| Aug 7, 1995 | K952278 | THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA General Surgical Innovations | GCJ |
| Jun 29, 1995 | K951878 | SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA General Surgical Innovations | GCJ |
| Nov 1, 1994 | K944418 | THE SPACEMAKER AND THE SPACEMAKER II General Surgical Innovations | GCJ |
| Oct 5, 1994 | K944536 | GSI KNOTMAKER General Surgical Innovations | GCJ |
| Aug 9, 1994 | K943671 | GSI CANNULA REDUCER ACCESSORY General Surgical Innovations | GCJ |
| Jul 7, 1994 | K941249 | SPECIMEN REMOVAL DEVICE General Surgical Innovations | GCJ |
| Feb 22, 1994 | K931425 | SURGICAL PATCH SPREADER General Surgical Innovations | GCJ |
| Jun 25, 1993 | K926010 | SURGICAL DISSECTOR WITH CANNULA General Surgical Innovations | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||