The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step Holders.
| Device ID | K021707 |
| 510k Number | K021707 |
| Device Name: | SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-23 |
| Decision Date | 2002-08-14 |
| Summary: | summary |