EnCor EnspireBreast Biopsy System (E4115, E4230) +4 more— 510(k) K233220

Clearance details

Device name as filed

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)

Applicant

Senorx, Inc.

Product code

Code KNW

Device class

Class 2

Regulation

21 CFR 876.1075

Advisory panel

Gastroenterology, Urology

Date received

2023-09-28

Decision date

2023-10-27

Decision

Substantially Equivalent

Clearance type

Special

Location

Tempe, AZ, US

• K260517 — Automatic Core Biopsy Instrument2026-08-28
• K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System2026-08-14
• K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
• K260572 — Marrow Marxman2026-08-04
• K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

• K210654 — EnCor Breast Biopsy Probe with Rinse Tube2021-03-31
• K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer2016-07-19
• K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER2013-06-27
• K093512 — ENCOR BREAST BIOPSY SYSTEM2009-11-20
• K092323 — CONTURA CAVITY MAINTENANCE CATHETER2009-08-19

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 →