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)
Top companies in KNW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Bard Peripheral Vascular Inc EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software Open, Classified |
KNW | K252681 |
| Jul 10, 2026 | Argon Medical Devices, Inc Bone Marrow Tray, REF: CB0033TL; CB0355TLA Open, Classified |
KNW | K980196 |
| Jul 10, 2026 | Argon Medical Devices, Inc T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL Open, Classified |
KNW | K980196 |
| Jul 10, 2026 | Argon Medical Devices, Inc General Biospy Tray, REF: GUTS1000 Open, Classified |
KNW | K980196 |
| Feb 6, 2026 | Hologic, Inc Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. Open, Classified |
KNW | K163052 |
| Feb 13, 2025 | Hologic, 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 |
KNW | K150169 |
| Nov 15, 2024 | Bard 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 |
KNW | K133948 |
| Sep 20, 2024 | Argon 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 |
KNW | K904987 K982960 |
| Jan 5, 2024 | Bard 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 |
KNW | K171953 |
| Oct 4, 2023 | Bard Peripheral Vascular Inc Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 Open, Classified |
KNW | K133948 |
| Jun 29, 2023 | Hologic, 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 |
KNW | K150169 |
| May 5, 2023 | Bard Peripheral Vascular Inc Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM Open, Classified |
KNW | K171953 |
| Mar 16, 2023 | Bard Peripheral Vascular Inc Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK Open, Classified |
KNW | K171953 |
| Dec 28, 2022 | Remington Medical, Inc. Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1) Terminated |
KNW | K191315 |
| Oct 27, 2022 | Merit 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 |
KNW | K180450 |
| Oct 27, 2022 | Merit 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 |
KNW | K180450 |
| Oct 4, 2021 | Argon 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 |
KNW | K974814 |
| Aug 24, 2021 | Bard 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 |
KNW | K171531 K913306 |
| Aug 24, 2021 | Bard 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 |
KNW | K171531 |
| Aug 5, 2021 | M.D.L. S.r.l. Soft Tissue Biopsy Needles Terminated |
KNW | K160316 |
| Jun 23, 2021 | Bard 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 |
KNW | K930217 |
| Jun 23, 2021 | Bard Peripheral Vascular Inc EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm Open, Classified |
KNW | K171531 |
| Jun 23, 2021 | Bard 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 |
KNW | K171531 |
| May 19, 2021 | BIOPSYBELL S.R.L. BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111 Terminated |
KNW | K130616 |
| Apr 7, 2021 | Arrow 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 |
KNW | K113872 |
| Jan 14, 2021 | Bard 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 |
KNW | K133948 |
| Mar 17, 2020 | Bard 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 |
KNW | K171531 |
| Jan 3, 2020 | Bard 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 |
KNW | K040842 K051158 |
| Jan 3, 2020 | Bard 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 |
KNW | K040842 K051158 |
| Jan 3, 2020 | Bard 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 |
KNW | K040842 K051158 |
| Jan 3, 2020 | Bard 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 |
KNW | K040842 K051158 |
| Dec 23, 2019 | Zimmer Biomet, Inc. Jamshidi Bone Marrow Aspiration Needle
Item Number: 00-1103-007-00 Terminated |
KNW | None listed |
| Dec 2, 2019 | Argon 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 |
KNW | K904987 |
| Oct 25, 2019 | Bard 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 |
KNW | K133948 |
| Aug 1, 2019 | Becton Dickinson & Company 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC
Catalog Number: TMJ4008 Terminated |
KNW | K171531 |
| May 2, 2019 | Bard 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 |
KNW | K040842 K051158 |
| May 2, 2019 | Bard 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 |
KNW | K040842 K051158 |
| May 2, 2019 | Bard 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 |
KNW | K040842 K051158 |
| May 2, 2019 | Bard 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 |
KNW | K040842 K051158 |
| May 2, 2019 | Bard 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 |
KNW | K040842 K051158 |
| May 2, 2019 | Bard 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 |
KNW | K040842 K051158 |
| Apr 18, 2019 | K2M, 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 |
KNW | K152872 |
| Apr 18, 2019 | K2M, 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 |
KNW | K152872 |
| Feb 18, 2019 | Avitus 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 |
KNW | K170539 |
| Feb 18, 2019 | Avitus 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 |
KNW | K152474 |
| Sep 22, 2017 | Bard 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 |
KNW | K133948 |
| Mar 8, 2017 | Devicor 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 |
KNW | K152989 |
| Feb 13, 2017 | Argon Medical Devices, Inc HARVEST NEEDLE 15GA X 2
Intended for the purpose of harvesting bone and/or bone marrow specimens Terminated |
KNW | K980196 |
| Feb 13, 2017 | Argon 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 |
KNW | K980196 |
| Feb 13, 2017 | Argon 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 |
KNW | K980196 |
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