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

DateFirm and productCodeLinked 510(k)
Sep 25, 2026Bard Peripheral Vascular Inc
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Open, Classified
KNWK252681
Jul 10, 2026Argon Medical Devices, Inc
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Open, Classified
KNWK980196
Jul 10, 2026Argon Medical Devices, Inc
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Open, Classified
KNWK980196
Jul 10, 2026Argon Medical Devices, Inc
General Biospy Tray, REF: GUTS1000
Open, Classified
KNWK980196
Feb 6, 2026Hologic, Inc
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Open, Classified
KNWK163052
Feb 13, 2025Hologic, Inc
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Open, Classified
KNWK150169
Nov 15, 2024Bard Peripheral Vascular Inc
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13
Open, Classified
KNWK133948
Sep 20, 2024Argon Medical Devices, Inc
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370
Open, Classified
KNWK904987
K982960
Jan 5, 2024Bard Peripheral Vascular Inc
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810M
Open, Classified
KNWK171953
Oct 4, 2023Bard Peripheral Vascular Inc
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Open, Classified
KNWK133948
Jun 29, 2023Hologic, Inc
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Open, Classified
KNWK150169
May 5, 2023Bard Peripheral Vascular Inc
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Open, Classified
KNWK171953
Mar 16, 2023Bard Peripheral Vascular Inc
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Open, Classified
KNWK171953
Dec 28, 2022Remington Medical, Inc.
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Terminated
KNWK191315
Oct 27, 2022Merit Medical Systems, Inc.
CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA18
Open, Classified
KNWK180450
Oct 27, 2022Merit Medical Systems, Inc.
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CO
Open, Classified
KNWK180450
Oct 4, 2021Argon Medical Devices, Inc
SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060
Open, Classified
KNWK974814
Aug 24, 2021Bard Peripheral Vascular Inc
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to
Terminated
KNWK171531
K913306
Aug 24, 2021Bard Peripheral Vascular Inc
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, F
Terminated
KNWK171531
Aug 5, 2021M.D.L. S.r.l.
Soft Tissue Biopsy Needles
Terminated
KNWK160316
Jun 23, 2021Bard Peripheral Vascular Inc
TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Open, Classified
KNWK930217
Jun 23, 2021Bard Peripheral Vascular Inc
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Open, Classified
KNWK171531
Jun 23, 2021Bard Peripheral Vascular Inc
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown B
Open, Classified
KNWK171531
May 19, 2021BIOPSYBELL S.R.L.
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
Terminated
KNWK130616
Apr 7, 2021Arrow International Inc
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended
Open, Classified
KNWK113872
Jan 14, 2021Bard Peripheral Vascular Inc
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
Terminated
KNWK133948
Mar 17, 2020Bard Peripheral Vascular Inc
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner
Terminated
KNWK171531
Jan 3, 2020Bard Peripheral Vascular Inc
Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Terminated
KNWK040842
K051158
Jan 3, 2020Bard Peripheral Vascular Inc
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Terminated
KNWK040842
K051158
Jan 3, 2020Bard Peripheral Vascular Inc
Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Terminated
KNWK040842
K051158
Jan 3, 2020Bard Peripheral Vascular Inc
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Terminated
KNWK040842
K051158
Dec 23, 2019Zimmer Biomet, Inc.
Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
Terminated
KNWNone listed
Dec 2, 2019Argon Medical Devices, Inc
BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to o
Terminated
KNWK904987
Oct 25, 2019Bard Peripheral Vascular Inc
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymp
Terminated
KNWK133948
Aug 1, 2019Becton Dickinson & Company
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Terminated
KNWK171531
May 2, 2019Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in ac
Terminated
KNWK040842
K051158
May 2, 2019Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for dia
Terminated
KNWK040842
K051158
May 2, 2019Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in
Terminated
KNWK040842
K051158
May 2, 2019Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in acquiring tissue for
Terminated
KNWK040842
K051158
May 2, 2019Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in
Terminated
KNWK040842
K051158
May 2, 2019Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for
Terminated
KNWK040842
K051158
Apr 18, 2019K2M, Inc
Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for dia
Terminated
KNWK152872
Apr 18, 2019K2M, Inc
Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone
Terminated
KNWK152872
Feb 18, 2019Avitus Orthopaedics, Inc.
Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus Bone Harvester is intended to harvest cancellous bone and bone marr
Terminated
KNWK170539
Feb 18, 2019Avitus Orthopaedics, Inc.
Avitus Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus Bone Harvester is intended to harvest cancellous bone and bone mar
Terminated
KNWK152474
Sep 22, 2017Bard Peripheral Vascular Inc
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy
Terminated
KNWK133948
Mar 8, 2017Devicor Medical Products Inc
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Terminated
KNWK152989
Feb 13, 2017Argon Medical Devices, Inc
HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
Terminated
KNWK980196
Feb 13, 2017Argon Medical Devices, Inc
T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens
Terminated
KNWK980196
Feb 13, 2017Argon Medical Devices, Inc
BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
Terminated
KNWK980196

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