KNW
- Product code
- KNW
- Device name
- Instrument, Biopsy
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1075
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 26
- Summaries archived here
- 23 (direct download)
- 510(k) clearances (all years, FDA)
- 365 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (26)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260517 | 2026-08-28 | Zhejiang Curaway Medical Technology Co… | Automatic Core Biopsy Instrument | |
| K262571 | 2026-08-14 | Bard Peripheral Vascular, Inc. | EnCor EnCompass Breast Biopsy and Tissue Removal Sy… | |
| K262792 | 2026-08-12 | Hologic, Inc. | Brevera Biopsy System with CorLumina Imaging Technol… | FDA |
| K260572 | 2026-08-04 | Medimetrix, LLC | Marrow Marxman | |
| K261196 | 2026-05-12 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed VeriEcto Automatic Biopsy Needles | |
| K260365 | 2026-03-04 | Devicor Medical Products, Inc. | Mammotome Prima MR Dual Vacuum-Assisted Breast Biop… | |
| K252795 | 2026-02-23 | Argon Medical Devices, Inc. | ZeniCore Automatic Biopsy Instrument (863212100 / … | |
| K252681 | 2025-12-12 | Bard Peripheral Vascular, Inc. | EnCor EnCompass Breast Biopsy and Tissue Removal Sy… | |
| K252183 | 2025-09-24 | Resitu Medical AB | Resitu Slider 09 (RESL09) | FDA |
| K243407 | 2025-07-29 | Forcyte Medical, LLC | Forcyte Autograft Harvest Kit | |
| K244018 | 2025-07-22 | Zhejiang Curaway Medical Technology Co… | Disposable Biopsy Needle | |
| K243296 | 2025-07-11 | Carbon (Shenzhen) Medical Device Co., … | Disposable Biopsy Needle | |
| K250032 | 2025-07-10 | Bard Peripheral Vascular, Inc. | Marquee Disposable Core Biopsy Instrument and Instr… | |
| K243886 | 2025-04-29 | Inrad, Inc. | ExpressCore Biopsy Device | |
| K243945 | 2025-04-24 | SurGenTec, LLC | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMA… | |
| K242128 | 2025-02-27 | Xaga Surgical | Forsvall biopsy needle system for prostate biopsy (F… | FDA |
| K242322 | 2025-01-24 | Zhejiang Curaway Medical Technology Co… | Bone Marrow Biopsy Needle | |
| K241793 | 2025-01-24 | Zhejiang Curaway Medical Technology Co… | Automatic Core Biopsy Instrument/ Semi-Automatic Cor… | |
| K242228 | 2025-01-10 | Triopsy Medical, Inc. | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN… | |
| K243095 | 2024-10-29 | Devicor Medical Products, Inc. | Mammotome AutoCore Single Insertion Core Biopsy Sys… | |
| K242029 | 2024-10-09 | H.S Hospital Service S.P.A | TRAP EASY | |
| K240664 | 2024-08-09 | SurGenTec, LLC | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMA… | |
| K233294 | 2024-06-18 | Itp Innovative Tomography Products Gmb… | Automatic Biopsy Needle BAM, Semi-Automatic Needle B… | |
| K233031 | 2024-01-17 | Canyon Medical, Inc. | M·Biopsy /SureCore Automatic Disposable Biopsy Needl… | |
| K230646 | 2023-11-29 | Uro-1 Medical, Inc. | SUREcore Prime Biopsy Instrument | |
| K233220 | 2023-10-27 | Senorx, Inc. | EnCor EnspireBreast Biopsy System (E4115, E4230); E… |
Official FDA classification page: KNW
Classification and pathway per current FDA publications. Data from openFDA (CC0).