Cleared Traditional

K260365 - Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module (FDA 510(k) Clearance)

Also includes:

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

K260365 · Devicor Medical Products, Inc. · General & Plastic Surgery device

Mar 2026

Decision

28d

Days

Class 2

Risk

K260365 is an FDA 510(k) clearance for the Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).

Submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 4, 2026, 28 days after receiving the submission on February 4, 2026.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number	K260365 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 04, 2026
Decision Date	March 04, 2026
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF