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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260365 · Devicor Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 4, 2026 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Devicor Medical Products, Inc. devices

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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 114d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNW Instrument, Biopsy

All 359
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K260365.
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit)
K252795 · Argon Medical Devices, Inc. · Feb 2026
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · Bard Peripheral Vascular, Inc. · Dec 2025
Resitu Slider 09 (RESL09)
K252183 · Resitu Medical AB · Sep 2025
Forcyte Autograft Harvest Kit
K243407 · Forcyte Medical, LLC · Jul 2025
Disposable Biopsy Needle
K244018 · Zhejiang Curaway Medical Technology Co., Ltd. · Jul 2025
Disposable Biopsy Needle
K243296 · Carbon (Shenzhen) Medical Device Co., Ltd. · Jul 2025