Surgrx, Inc.
Mountain View, CA, US
Surgrx, Inc. appears in FDA device records in Mountain View, CA. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Surgrx, Inc. between 2003 and 2008. The busiest year on record is 2007, with 5. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 5 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K081129 | ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL | GEI | Substantially Equivalent | |
| K072493 | ENSEAL TISSUE SEALING DEVICE | GEI | Substantially Equivalent | |
| K072177 | ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM | GEI | Substantially Equivalent | |
| K071728 | MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE | GEI | Substantially Equivalent | |
| K070896 | ENSEAL PTC TISSUE SEALING DEVICE | GEI | Substantially Equivalent | |
| K070165 | ENSEAL PTC TRIO | GEI | Substantially Equivalent | |
| K063097 | ENSEAL PTC TISSUE SEALING DEVICE | GEI | Substantially Equivalent | |
| K062949 | ENSEAL PTC TISSUE SEATING SEALING DEVICE | GEI | Substantially Equivalent | |
| K061526 | ENSEAL PTC TISSUE SEALING DEVICE | GEI | Substantially Equivalent | |
| K050671 | ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | GEI | Substantially Equivalent | |
| K043008 | SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | GEI | Substantially Equivalent | |
| K031133 | SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS | GEI | 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
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Data as of , FDA export datePage updated Source: openFDA, public domain