About This 510(k) Submission
K260365 is an FDA 510(k) clearance for the 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, 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 review panel. Regulated under 21 CFR 876.1075.