Device Classification Name |
instrument, biopsy
|
510(k) Number |
K233220 |
Device Name |
EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110G |
Applicant |
SenoRx, Inc. |
1625 West 3rd Street |
Tempe,
AZ
85251
|
|
Applicant Contact |
Kathryn Swanstrom |
Correspondent |
SenoRx, Inc. |
1625 West 3rd Street |
Tempe,
AZ
85251
|
|
Correspondent Contact |
Kathryn Swanstrom |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 09/28/2023 |
Decision Date | 10/27/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|