The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Anchor Guide Lesion Localization Device; Ancor Guide Holder; Rf Generator Cable.
| Device ID | K012023 |
| 510k Number | K012023 |
| Device Name: | ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE |
| 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 | 2001-06-28 |
| Decision Date | 2001-09-12 |
| Summary: | summary |