KNW
VACUUM ASSISTED CORE BIOPSY DEVICE
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 360
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KNW
1–100 of 360- K260365 — 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
- K252795 — 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
- K252681 — EnCor EnCompass Breast Biopsy and Tissue Removal System
- K252183 — Resitu Slider 09 (RESL09)
- K243407 — Forcyte Autograft Harvest Kit
- K244018 — Disposable Biopsy Needle
- K243296 — Disposable Biopsy Needle
- K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit
- K243886 — ExpressCore Biopsy Device
- K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
- K242128 — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
- K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
- K242322 — Bone Marrow Biopsy Needle
- K242228 — Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
- K243095 — Mammotome AutoCore Single Insertion Core Biopsy System
- K242029 — TRAP EASY
- K240664 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
- K233294 — Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
- K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
- K230646 — SUREcore Prime Biopsy Instrument
- K233220 — EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)
- K230015 — OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver
- K223300 — Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
- K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
- K223612 — Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
- K222462 — Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)
- K220611 — SUREcore Plus Biopsy Instrument
- K220595 — NeoNavia Biopsy System
- K212820 — Disposable Semi Automatic Biopsy Instrument
- K213232 — NovaCore Semi-Automatic Biopsy Instrument
- K214063 — Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
- K213683 — Promisemed Fine Biopsy Needle
- K213896 — BD Trek Powered Bone Biopsy System
- K212079 — TeesuVac Breast Biopsy Device Mark 1
- K213213 — Arthrex Vortex Threaded Bone Marrow Recovery Needle
- K212284 — Disposable Automatic Core Biopsy Instrument
- K203141 — Uramix CuraWay Biopsy Needle
- K210946 — Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
- K211933 — EleVation Breast Biopsy System
- K210631 — Avitus(r) Bone Harvester
- K210654 — EnCor Breast Biopsy Probe with Rinse Tube
- K201650 — VMCore Biopsy Needle
- K203397 — Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
- K202287 — Ran-Flex-B Bone Marrow Aspiration Needle
- K201166 — Temno Elite Biopsy System
- K202012 — Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
- K201244 — Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
- K192099 — MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
- K192101 — Medone Ultra, Medextra
- K200278 — CytoCore
- K193268 — APrioCore Plus
- K192948 — EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
- K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC)
- K190177 — J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
- K190378 — Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
- K183146 — Ranfac Cartilage Biopsy Needle
- K181803 — Medax Biopsy Systems III
- K171890 — BEXCORE Breast Biopsy System, Biopsy Needle
- K173316 — SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device
- K180807 — Celling Aspiration Needle
- K180233 — Eviva Stereotactic Guided Breast Biopsy System
- K180450 — Corvocet Biopsy System
- K180327 — Stryker iVAS 13g Bone Biopsy Kit
- K172344 — Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
- K172558 — iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
- K171953 — Bard Mission Disposable Core Biopsy Instrument
- K171531 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
- K162588 — Möller Medical Biopsy Needles and Systems
- K163052 — Brevera Biopsy System with Corlumina Imaging Technology
- K170539 — Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
- K170008 — Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
- K160316 — SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
- K153709 — Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet
- K161234 — CASSI II Rotational Core Biopsy System
- K161409 — M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
- K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer
- K153337 — Corvocet Biopsy System
- K152989 — Mammotome revolve Dual Vacuum Assist Biopsy System
- K152596 — Intact® Gen2 System
- K152872 — K2M Fenestrated Tap System
- K142125 — New Medax Biopsy Systems
- K153306 — Imbibe Needle
- K152474 — Avitus Bone Harvester
- K150169 — Sertera Biopsy Device
- K150088 — Evacore Fully Disposable Vacuum Assist Biopsy Device
- K150625 — Morrison Steerable Needle
- K150563 — Marrow Cellution Bone Marrow Aspiration Needle
- K141910 — Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
- K143546 — Imbibe Aspirating XIA Taps
- K142791 — Spectra Soft Tissue Biopsy Needles
- K142377 — The OnControl Bone Marrow Biopsy System by Vidacare
- K142477 — Intact Advance and Intact Excision XL, Intact BLES
- K140991 — RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
- K141552 — ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
- K141673 — IVAS 8 GAUGE BONE BIOPSY KIT
- K133702 — PRESTO BREAST BIOPSY DEVICE
- K133948 — BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
- K130616 — MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
- K131157 — RANFAC BONE MARROW ASPIRATION NEEDLE
- K130282 — REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.