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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2026 | K260517 | Automatic Core Biopsy Instrument Zhejiang Curaway Medical Technology Co., Ltd., CN | KNW |
| Aug 14, 2026 | K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System Bard Peripheral Vascular, Inc. | KNW |
| Aug 12, 2026 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) Hologic, Inc. | KNW |
| Aug 4, 2026 | K260572 | Marrow Marxman Medimetrix, LLC | KNW |
| May 12, 2026 | K261196 | Promisemed VeriEcto Automatic Biopsy Needles Promisemed Hangzhou Meditech Co., Ltd., CN | KNW |
| Mar 4, 2026 | K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted B Devicor Medical Products, Inc. | KNW |
| Feb 23, 2026 | K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Argon Medical Devices, Inc. | KNW |
| Dec 12, 2025 | K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System Bard Peripheral Vascular, Inc. | KNW |
| Sep 24, 2025 | K252183 | Resitu Slider 09 (RESL09) Resitu Medical AB, SE | KNW |
| Jul 29, 2025 | K243407 | Forcyte Autograft Harvest Kit Forcyte Medical, LLC | KNW |
| Jul 22, 2025 | K244018 | Disposable Biopsy Needle Zhejiang Curaway Medical Technology Co., Ltd., CN | KNW |
| Jul 11, 2025 | K243296 | Disposable Biopsy Needle Carbon (Shenzhen) Medical Device Co., Ltd., CN | KNW |
| Jul 10, 2025 | K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit Bard Peripheral Vascular, Inc. | KNW |
| Apr 29, 2025 | K243886 | ExpressCore Biopsy Device Inrad, Inc. | KNW |
| Apr 24, 2025 | K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) SurGenTec, LLC | KNW |
| Feb 27, 2025 | K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) Xaga Surgical, SE | KNW |
| Jan 24, 2025 | K242322 | Bone Marrow Biopsy Needle Zhejiang Curaway Medical Technology Co., Ltd., CN | KNW |
| Jan 24, 2025 | K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle Zhejiang Curaway Medical Technology Co., Ltd., CN | KNW |
| Jan 10, 2025 | K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) Triopsy Medical, Inc. | KNW |
| Oct 29, 2024 | K243095 | Mammotome AutoCore Single Insertion Core Biopsy System Devicor Medical Products, Inc. | KNW |
| Oct 9, 2024 | K242029 | TRAP EASY H.S Hospital Service S.P.A, IT | KNW |
| Aug 9, 2024 | K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) SurGenTec, LLC | KNW |
| Jun 18, 2024 | K233294 | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM Itp Innovative Tomography Products GmbH, DE | KNW |
| Jan 17, 2024 | K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Bio Canyon Medical, Inc., CN | KNW |
| Nov 29, 2023 | K230646 | SUREcore Prime Biopsy Instrument Uro-1 Medical, Inc. | KNW |
| Oct 27, 2023 | K233220 | EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Drive Senorx, Inc. | KNW |
| Jun 16, 2023 | K230015 | OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver Laurane Medical Sas, FR | KNW |
| Apr 21, 2023 | K223300 | Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxico Geotek Medikal Ltd Sti, TR | KNW |
| Apr 3, 2023 | K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Bio Canyon Medical, Inc., CN | KNW |
| Feb 21, 2023 | K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) Ranfac Corporation | KNW |
| Jan 20, 2023 | K222462 | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18 Itp Innovative Tomography Products GmbH, DE | KNW |
| Dec 2, 2022 | K220611 | SUREcore Plus Biopsy Instrument Uro-1, Inc. | KNW |
| Sep 8, 2022 | K220595 | NeoNavia Biopsy System Neodynamics AB, SE | KNW |
| Jul 6, 2022 | K212820 | Disposable Semi Automatic Biopsy Instrument Suzhou Leapmed Healthcare Corporation, CN | KNW |
| Jul 1, 2022 | K213232 | NovaCore Semi-Automatic Biopsy Instrument Argon Medical Devices | KNW |
| Jun 3, 2022 | K214063 | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needl Guangzhou Shengwei Medical Devices Co., Ltd., CN | KNW |
| Apr 22, 2022 | K213683 | Promisemed Fine Biopsy Needle Promisemed Hangzhou Meditech Co., Ltd., CN | KNW |
| Mar 30, 2022 | K213896 | BD Trek Powered Bone Biopsy System Bard Peripheral Vascular | KNW |
| Feb 2, 2022 | K212079 | TeesuVac Breast Biopsy Device Mark 1 Teesuvac Aps, DK | KNW |
| Nov 19, 2021 | K213213 | Arthrex Vortex Threaded Bone Marrow Recovery Needle Arthrex, Inc. | KNW |
| Nov 10, 2021 | K212284 | Disposable Automatic Core Biopsy Instrument Suzhou Leapmed Healthcare Corporation, CN | KNW |
| Sep 17, 2021 | K203141 | Uramix CuraWay Biopsy Needle Uramix, Inc. | KNW |
| Aug 12, 2021 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles Promisemed Hangzhou Meditech Co., Ltd., CN | KNW |
| Jul 15, 2021 | K211933 | EleVation Breast Biopsy System Bard Peripheral Vascular | KNW |
| Mar 31, 2021 | K210654 | EnCor Breast Biopsy Probe with Rinse Tube Senorx, Inc. | KNW |
| Mar 31, 2021 | K210631 | Avitus(r) Bone Harvester Avitus Orthopaedics, Inc. | KNW |
| Jan 15, 2021 | K201650 | VMCore Biopsy Needle Uro-1, Inc. | KNW |
| Jan 11, 2021 | K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- Biopsybell S.R.L., IT | KNW |
| Sep 18, 2020 | K202287 | Ran-Flex-B Bone Marrow Aspiration Needle Ranfac Corporation | KNW |
| Aug 28, 2020 | K201166 | Temno Elite Biopsy System Merit Medical Systems, Inc. | KNW |
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