ClearanceBrief
Panels › Gastroenterology, Urology › Product code KNW · Class 2

Instrument, Biopsy

Regulation 876.1075

8510(k)s in 12 months (365 all time)
5recalls in 12 months (107 all time)
103recalls that name a 510(k)
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Top companies in KNW

Company510(k)sRecalls
Bard Peripheral Vascular828
Medical Device Technologies, Inc.157
Argon Medical Devices211
Remington Medical, Inc.49
C.R. Bard, Inc.110
Hologic, Inc.47
Medtronic Advanced Energy, LLC011
Gallini U.S., LLC100
Manan Medical Products, Inc.100
Daum Corp.90
Decided510(k)Device and applicantCode
Aug 18, 2020K202012Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
Devicor Medical Products, Inc.
KNW
Aug 7, 2020K201244Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
Transmed7, LLC
KNW
Apr 2, 2020K192101Medone Ultra, Medextra
Medax Srl Unipersonale, IT
KNW
Apr 2, 2020K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System
Medax Srl Unipersonale, IT
KNW
Mar 31, 2020K200278CytoCore
Praxis Medical, LLC
KNW
Feb 27, 2020K193268APrioCore Plus
Apriomed AB, SE
KNW
Nov 7, 2019K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
Bard Peripheral Vascular, Inc.
KNW
Jul 12, 2019K191315Remington Medical, Inc. Automatic Cutting Needle (NAC)
Remington Medical, Inc.
KNW
Jun 12, 2019K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
Ranfac Corporation
KNW
May 24, 2019K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
Bioncise NV, BE
KNW
Apr 25, 2019K183146Ranfac Cartilage Biopsy Needle
Ranfac Corporation
KNW
Oct 18, 2018K181803Medax Biopsy Systems III
Medax Srl Unipersonale, IT
KNW
Aug 20, 2018K171890BEXCORE Breast Biopsy System, Biopsy Needle
Medical Park Co., Ltd., KR
KNW
Jun 19, 2018K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Sof
Transmed7, LLC
KNW
May 24, 2018K180807Celling Aspiration Needle
Spine Smith Holdings, LLC
KNW
Apr 10, 2018K180233Eviva Stereotactic Guided Breast Biopsy System
Hologic, Inc.
KNW
Mar 12, 2018K180450Corvocet Biopsy System
Merit Medical Systems, Inc.
KNW
Feb 26, 2018K180327Stryker iVAS 13g Bone Biopsy Kit
Stryker Corporation
KNW
Nov 13, 2017K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
Medax Srl Unipersonale, IT
KNW
Oct 5, 2017K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
Stryker Corporation
KNW
Sep 14, 2017K171953Bard Mission Disposable Core Biopsy Instrument
Bard Peripheral Vascular, Inc.
KNW
Sep 11, 2017K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve B
Care Fusion
KNW
Jun 19, 2017K162588Möller Medical Biopsy Needles and Systems
Moller Medical GmbH, DE
KNW
Mar 29, 2017K163052Brevera Biopsy System with Corlumina Imaging Technology
Hologic, Inc.
KNW
Mar 20, 2017K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert -
Avitus Orthopaedics, Inc.
KNW
Feb 28, 2017K170008Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
Cook Incorporated
KNW
Oct 27, 2016K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device,
M.D.L. S.R.L., IT
KNW
Aug 8, 2016K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster,
Devicor Medical Products, Inc.
KNW
Aug 3, 2016K161234CASSI II Rotational Core Biopsy System
Scion Medical Technologies, LLC
KNW
Aug 2, 2016K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
Mermaid Medical A/S, DK
KNW
Jul 19, 2016K161805EnCor MRI Introducer Set, EnCor Probe Introducer
Senorx, Inc.
KNW
Mar 25, 2016K153337Corvocet Biopsy System
Merit Medical Systems, Inc.
KNW
Feb 25, 2016K152989Mammotome revolve Dual Vacuum Assist Biopsy System
Devicor Medical Products, Inc.
KNW
Feb 15, 2016K152596Intact® Gen2 System
Intact Medical Corporation
KNW
Jan 5, 2016K152872K2M Fenestrated Tap System
K2m
KNW
Dec 22, 2015K142125New Medax Biopsy Systems
Medax Srl Unipersonale, IT
KNW
Dec 18, 2015K153306Imbibe Needle
Orthovita, Inc.
KNW
Oct 23, 2015K152474Avitus Bone Harvester
Avitus Orthopaedics, Inc.
KNW
Aug 14, 2015K150169Sertera Biopsy Device
Hologic, Inc.
KNW
Jul 20, 2015K150088Evacore Fully Disposable Vacuum Assist Biopsy Device
Pin-Point Care Corp.
KNW
Jun 9, 2015K150625Morrison Steerable Needle
Apriomed AB, SE
KNW
May 22, 2015K150563Marrow Cellution Bone Marrow Aspiration Needle
Ranfac, Corp.
KNW
May 4, 2015K141910Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
Biologic Therapies, Inc.
KNW
Mar 19, 2015K143546Imbibe Aspirating XIA Taps
Stryker Corporation
KNW
Jan 21, 2015K142791Spectra Soft Tissue Biopsy Needles
Spectra Medical Devices
KNW
Dec 17, 2014K142377The OnControl Bone Marrow Biopsy System by Vidacare
Vidacare, LLC
KNW
Dec 15, 2014K142477Intact Advance and Intact Excision XL, Intact BLES
Intact Medical Corporation
KNW
Sep 11, 2014K140991RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
Ranfac, Corp.
KNW
Sep 5, 2014K141552ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
Care Fusion
KNW
Sep 4, 2014K141673IVAS 8 GAUGE BONE BIOPSY KIT
Stryker Corporation
KNW

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