FDA Product Code
FDA Product Code KNW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1075
510(k) Clearances — 365 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | 2026-08-28 | Traditional | PDF ↗ |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2026-08-14 | Special | PDF ↗ |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | 2026-08-12 | Special | PDF ↗ |
| K260572 | Marrow Marxman | Medimetrix, LLC | 2026-08-04 | Traditional | PDF ↗ |
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 | Special | PDF ↗ |
| 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 | Devicor Medical Products, Inc. | 2026-03-04 | Traditional | PDF ↗ |
| 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 | Argon Medical Devices, Inc. | 2026-02-23 | Traditional | PDF ↗ |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025-12-12 | Traditional | PDF ↗ |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 2025-09-24 | Traditional | PDF ↗ |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025-07-29 | Traditional | PDF ↗ |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 | Traditional | PDF ↗ |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 | Traditional | PDF ↗ |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | 2025-07-10 | Special | PDF ↗ |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | 2025-04-29 | Traditional | PDF ↗ |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025-04-24 | Traditional | PDF ↗ |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical | 2025-02-27 | Traditional | PDF ↗ |
| K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 | Traditional | PDF ↗ |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 | Traditional | PDF ↗ |
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) | Triopsy Medical, Inc. | 2025-01-10 | Traditional | PDF ↗ |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | Devicor Medical Products, Inc. | 2024-10-29 | Traditional | PDF ↗ |
| K242029 | TRAP EASY | H.S Hospital Service S.P.A | 2024-10-09 | Traditional | PDF ↗ |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024-08-09 | Traditional | PDF ↗ |
| K233294 | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | Itp Innovative Tomography Products GmbH | 2024-06-18 | Traditional | PDF ↗ |
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical, Inc. | 2024-01-17 | Traditional | PDF ↗ |
| K230646 | SUREcore Prime Biopsy Instrument | Uro-1 Medical, Inc. | 2023-11-29 | Traditional | PDF ↗ |
| 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) | Senorx, Inc. | 2023-10-27 | Special | PDF ↗ |
| K230015 | OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver | Laurane Medical Sas | 2023-06-16 | Traditional | PDF ↗ |
| K223300 | Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument | Geotek Medikal Ltd Sti | 2023-04-21 | Traditional | PDF ↗ |
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical, Inc. | 2023-04-03 | Traditional | PDF ↗ |
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) | Ranfac Corporation | 2023-02-21 | Special | PDF ↗ |
| 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) | Itp Innovative Tomography Products GmbH | 2023-01-20 | Traditional | PDF ↗ |
| K220611 | SUREcore Plus Biopsy Instrument | Uro-1, Inc. | 2022-12-02 | Traditional | PDF ↗ |
| K220595 | NeoNavia Biopsy System | Neodynamics AB | 2022-09-08 | Traditional | PDF ↗ |
| K212820 | Disposable Semi Automatic Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | 2022-07-06 | Traditional | PDF ↗ |
| K213232 | NovaCore Semi-Automatic Biopsy Instrument | Argon Medical Devices | 2022-07-01 | Traditional | PDF ↗ |
| K214063 | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle | Guangzhou Shengwei Medical Devices Co., Ltd. | 2022-06-03 | Traditional | PDF ↗ |
| K213683 | Promisemed Fine Biopsy Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022-04-22 | Traditional | PDF ↗ |
| K213896 | BD Trek Powered Bone Biopsy System | Bard Peripheral Vascular | 2022-03-30 | Traditional | PDF ↗ |
| K212079 | TeesuVac Breast Biopsy Device Mark 1 | Teesuvac Aps | 2022-02-02 | Traditional | PDF ↗ |
| K213213 | Arthrex Vortex Threaded Bone Marrow Recovery Needle | Arthrex, Inc. | 2021-11-19 | Traditional | PDF ↗ |
| K212284 | Disposable Automatic Core Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | 2021-11-10 | Traditional | PDF ↗ |
| K203141 | Uramix CuraWay Biopsy Needle | Uramix, Inc. | 2021-09-17 | Traditional | PDF ↗ |
| K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2021-08-12 | Traditional | PDF ↗ |
| K211933 | EleVation Breast Biopsy System | Bard Peripheral Vascular | 2021-07-15 | Special | PDF ↗ |
| K210631 | Avitus(r) Bone Harvester | Avitus Orthopaedics, Inc. | 2021-03-31 | Special | PDF ↗ |
| K210654 | EnCor Breast Biopsy Probe with Rinse Tube | Senorx, Inc. | 2021-03-31 | Special | PDF ↗ |
| K201650 | VMCore Biopsy Needle | Uro-1, Inc. | 2021-01-15 | Traditional | PDF ↗ |
| 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 | Biopsybell S.R.L. | 2021-01-11 | Traditional | PDF ↗ |
| K202287 | Ran-Flex-B Bone Marrow Aspiration Needle | Ranfac Corporation | 2020-09-18 | Traditional | PDF ↗ |
| K201166 | Temno Elite Biopsy System | Merit Medical Systems, Inc. | 2020-08-28 | Traditional | PDF ↗ |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | Devicor Medical Products, Inc. | 2020-08-18 | Traditional | PDF ↗ |
| K201244 | Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices | Transmed7, LLC | 2020-08-07 | Special | PDF ↗ |
| K192101 | Medone Ultra, Medextra | Medax Srl Unipersonale | 2020-04-02 | Traditional | PDF ↗ |
| 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 | Medax Srl Unipersonale | 2020-04-02 | Traditional | PDF ↗ |
| K200278 | CytoCore | Praxis Medical, LLC | 2020-03-31 | Traditional | PDF ↗ |
| K193268 | APrioCore Plus | Apriomed AB | 2020-02-27 | Traditional | PDF ↗ |
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G | Bard Peripheral Vascular, Inc. | 2019-11-07 | Special | PDF ↗ |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 2019-07-12 | Traditional | PDF ↗ |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, | Ranfac Corporation | 2019-06-12 | Special | PDF ↗ |
| K190378 | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix | Bioncise NV | 2019-05-24 | Traditional | PDF ↗ |
| K183146 | Ranfac Cartilage Biopsy Needle | Ranfac Corporation | 2019-04-25 | Traditional | PDF ↗ |
| K181803 | Medax Biopsy Systems III | Medax Srl Unipersonale | 2018-10-18 | Traditional | PDF ↗ |
| K171890 | BEXCORE Breast Biopsy System, Biopsy Needle | Medical Park Co., Ltd. | 2018-08-20 | Traditional | PDF ↗ |
| K173316 | SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device | Transmed7, LLC | 2018-06-19 | Traditional | PDF ↗ |
| K180807 | Celling Aspiration Needle | Spine Smith Holdings, LLC | 2018-05-24 | Traditional | PDF ↗ |
| K180233 | Eviva Stereotactic Guided Breast Biopsy System | Hologic, Inc. | 2018-04-10 | Traditional | PDF ↗ |
| K180450 | Corvocet Biopsy System | Merit Medical Systems, Inc. | 2018-03-12 | Special | PDF ↗ |
| K180327 | Stryker iVAS 13g Bone Biopsy Kit | Stryker Corporation | 2018-02-26 | Special | PDF ↗ |
| K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) | Medax Srl Unipersonale | 2017-11-13 | Traditional | PDF ↗ |
| K172558 | iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit | Stryker Corporation | 2017-10-05 | Traditional | PDF ↗ |
| K171953 | Bard Mission Disposable Core Biopsy Instrument | Bard Peripheral Vascular, Inc. | 2017-09-14 | Traditional | PDF ↗ |
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle | Care Fusion | 2017-09-11 | Traditional | PDF ↗ |
| K162588 | Möller Medical Biopsy Needles and Systems | Moller Medical GmbH | 2017-06-19 | Traditional | PDF ↗ |
| K163052 | Brevera Biopsy System with Corlumina Imaging Technology | Hologic, Inc. | 2017-03-29 | Traditional | PDF ↗ |
| 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 | Avitus Orthopaedics, Inc. | 2017-03-20 | Special | PDF ↗ |
| K170008 | Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set | Cook Incorporated | 2017-02-28 | Traditional | PDF ↗ |
| 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 | M.D.L. S.R.L. | 2016-10-27 | Traditional | PDF ↗ |
| 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 | Devicor Medical Products, Inc. | 2016-08-08 | Traditional | PDF ↗ |
| K161234 | CASSI II Rotational Core Biopsy System | Scion Medical Technologies, LLC | 2016-08-03 | Special | PDF ↗ |
| K161409 | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem | Mermaid Medical A/S | 2016-08-02 | Traditional | PDF ↗ |
| K161805 | EnCor MRI Introducer Set, EnCor Probe Introducer | Senorx, Inc. | 2016-07-19 | Special | PDF ↗ |
| K153337 | Corvocet Biopsy System | Merit Medical Systems, Inc. | 2016-03-25 | Traditional | PDF ↗ |
| K152989 | Mammotome revolve Dual Vacuum Assist Biopsy System | Devicor Medical Products, Inc. | 2016-02-25 | Traditional | PDF ↗ |
| K152596 | Intact® Gen2 System | Intact Medical Corporation | 2016-02-15 | Traditional | PDF ↗ |
| K152872 | K2M Fenestrated Tap System | K2m | 2016-01-05 | Traditional | PDF ↗ |
| K142125 | New Medax Biopsy Systems | Medax Srl Unipersonale | 2015-12-22 | Traditional | PDF ↗ |
| K153306 | Imbibe Needle | Orthovita, Inc. | 2015-12-18 | Special | PDF ↗ |
| K152474 | Avitus Bone Harvester | Avitus Orthopaedics, Inc. | 2015-10-23 | Traditional | PDF ↗ |
| K150169 | Sertera Biopsy Device | Hologic, Inc. | 2015-08-14 | Traditional | PDF ↗ |
| K150088 | Evacore Fully Disposable Vacuum Assist Biopsy Device | Pin-Point Care Corp. | 2015-07-20 | Traditional | PDF ↗ |
| K150625 | Morrison Steerable Needle | Apriomed AB | 2015-06-09 | Traditional | PDF ↗ |
| K150563 | Marrow Cellution Bone Marrow Aspiration Needle | Ranfac, Corp. | 2015-05-22 | Traditional | PDF ↗ |
| K141910 | Intraosseous Cannula System Bio-MAC¿ and Bio-CORE | Biologic Therapies, Inc. | 2015-05-04 | Traditional | PDF ↗ |
| K143546 | Imbibe Aspirating XIA Taps | Stryker Corporation | 2015-03-19 | Traditional | PDF ↗ |
| K142791 | Spectra Soft Tissue Biopsy Needles | Spectra Medical Devices | 2015-01-21 | Traditional | PDF ↗ |
| K142377 | The OnControl Bone Marrow Biopsy System by Vidacare | Vidacare, LLC | 2014-12-17 | Traditional | PDF ↗ |
| K142477 | Intact Advance and Intact Excision XL, Intact BLES | Intact Medical Corporation | 2014-12-15 | Traditional | PDF ↗ |
| K140991 | RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE | Ranfac, Corp. | 2014-09-11 | Traditional | PDF ↗ |
| K141552 | ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS | Care Fusion | 2014-09-05 | Traditional | PDF ↗ |
| K141673 | IVAS 8 GAUGE BONE BIOPSY KIT | Stryker Corporation | 2014-09-04 | Special | PDF ↗ |
Product code KNW · Class II · Gastroenterology, Urology. Data: openFDA.