General Surgical Innovations
Portola Valley, CA, US
General Surgical Innovations appears in FDA device records in Portola Valley, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for General Surgical Innovations between 1993 and 1999. The busiest year on record is 1994, with 5. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 5 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983318 | FIXATION SYSTEM | GDW | Substantially Equivalent | |
| K973046 | SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK | GCJ | Substantially Equivalent | |
| K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | FZW | Substantially Equivalent | |
| K970201 | GSI CANNULA WITH INTRODUCER | DYB | Substantially Equivalent | |
| K962702 | SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA | GCJ | Substantially Equivalent | |
| K961356 | MAMMARY SIZER | MRD | Substantially Equivalent for Some Indications | |
| K952278 | THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA | GCJ | Substantially Equivalent | |
| K951878 | SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA | GCJ | Substantially Equivalent | |
| K944418 | THE SPACEMAKER AND THE SPACEMAKER II | GCJ | Substantially Equivalent | |
| K944536 | GSI KNOTMAKER | GCJ | Substantially Equivalent | |
| K943671 | GSI CANNULA REDUCER ACCESSORY | GCJ | Substantially Equivalent | |
| K941249 | SPECIMEN REMOVAL DEVICE | GCJ | Substantially Equivalent | |
| K931425 | SURGICAL PATCH SPREADER | GCJ | Substantially Equivalent | |
| K926010 | SURGICAL DISSECTOR WITH CANNULA | GCJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets General Surgical Innovations edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for General Surgical Innovations. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain