Cleared Traditional

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System

K202012 · Devicor Medical Products, Inc. · General & Plastic Surgery
Aug 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K202012 is an FDA 510(k) clearance for the Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System, 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 August 18, 2020, 28 days after receiving the submission on July 21, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K202012 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2020
Decision Date August 18, 2020
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

Similar Devices — KNW Instrument, Biopsy

All 359
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
K260365 · Devicor Medical Products, Inc. · Mar 2026
ZeniCore? Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore? Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore? Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore? Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
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

More from Devicor Medical Products, Inc.

View all
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
K260365 · KNW · Mar 2026
HydroMARK? Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK? Plus Breast Biopsy Site Marker (Hummingbird Shape)
K253761 · NEU · Jan 2026
Mammotome AutoCore? Single Insertion Core Biopsy System
K243095 · KNW · Oct 2024
HydroMARK? Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
K240527 · NEU · Jul 2024
LumiMARK? Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK? Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK? Biopsy Site Marker (LM0215R (Rose shape))
K232615 · NEU · Jan 2024