← Back to catalogue

Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260365

by Devicor Medical Products, Inc.

Identifiers

510(k) Number
K260365 FDA 510(k)
FDA Product Code
KNW FDA 510(k)
Models / Variants
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module FDA 510(k)
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge FDA 510(k)
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge FDA 510(k)
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch FDA 510(k)
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray FDA 510(k)
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1075 FDA 510(k)
Regulation Number
876.1075 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5… by Devicor Medical Products, Inc. — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Devicor Medical Products, Inc.

Sources (1)

  • FDA 510(k) K260365 24 fields · synced Jun 18, 2026