The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Senorx Biopsy Device, Driver, Control Module, Including Accessories (power Cord,connector Cords And Footswitch), Vacuums.
| Device ID | K013641 |
| 510k Number | K013641 |
| Device Name: | SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
| Contact | Amy Boucly |
| Correspondent | Amy Boucly SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2002-01-29 |
| Summary: | summary |