| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 |
| 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 |
| 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 |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 2025-09-24 |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025-07-29 |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | 2025-07-10 |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | 2025-04-29 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025-04-24 |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical | 2025-02-27 |
| K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) | Triopsy Medical, Inc. | 2025-01-10 |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | Devicor Medical Products, Inc. | 2024-10-29 |
| K242029 | TRAP EASY | H.S Hospital Service S.P.A | 2024-10-09 |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024-08-09 |
| K233294 | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | Itp Innovative Tomography Products GmbH | 2024-06-18 |
| 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 |
| K230646 | SUREcore Prime Biopsy Instrument | Uro-1 Medical, Inc. | 2023-11-29 |
| 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 |
| K230015 | OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver | Laurane Medical Sas | 2023-06-16 |
| 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 |
| 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 |
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) | Ranfac Corporation | 2023-02-21 |
| 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 |
| K220611 | SUREcore Plus Biopsy Instrument | Uro-1, Inc. | 2022-12-02 |
| K220595 | NeoNavia Biopsy System | Neodynamics AB | 2022-09-08 |
| K212820 | Disposable Semi Automatic Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |