Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 more— 510(k) K260365

Clearance details

Device name as filed

Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char

Applicant

Devicor Medical Products, Inc.

Product code

Code KNW

Device class

Class 2

Regulation

21 CFR 876.1075

Advisory panel

Gastroenterology, Urology

Date received

2026-02-04

Decision date

2026-03-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cincinnati, OH, 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

• K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)2026-01-23
• K243095 — Mammotome AutoCore Single Insertion Core Biopsy System2024-10-29
• K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)2024-07-10
• K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)) +2 more2024-01-12
• K221961 — HydroMARK Plus Breast Biopsy Site Marker2023-07-13

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 →