EnCor EnspireBreast 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, ECPMR0110GBT)— 510(k) K233220

Substantially Equivalent

Senorx, Inc.

FDA 510(k) clearance K233220 for EnCor EnspireBreast 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, ECPMR0110GBT), Substantially Equivalent on 2023-10-27. Applicant: Senorx, Inc..

Clearance details

Applicant: Senorx, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-28
Decision date: 2023-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.