KNW — Instrument, Biopsy Class II
FDA product code KNW covers "Instrument, Biopsy", a Class II medical device regulated under 21 CFR 876.1075. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KNW
- Device Class
- Class II
- Regulation Number
- 876.1075
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260517 | Zhejiang Curaway Medical Technology Co | Automatic Core Biopsy Instrument | Aug 28, 2026 |
| K262571 | Bard Peripheral Vascular | EnCor EnCompass Breast Biopsy and Tissue Removal System | Aug 14, 2026 |
| K262792 | Hologic | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Aug 12, 2026 |
| K260572 | Medimetrix | Marrow Marxman | Aug 4, 2026 |
| K261196 | Promisemed Hangzhou Meditech Co | Promisemed VeriEcto Automatic Biopsy Needles | May 12, 2026 |
| K260365 | Devicor Medical Products | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma | Mar 4, 2026 |
| K252795 | Argon Medical Devices | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy De | Feb 23, 2026 |
| K252681 | Bard Peripheral Vascular | EnCor EnCompass Breast Biopsy and Tissue Removal System | Dec 12, 2025 |
| K252183 | Resitu Medical | Resitu Slider 09 (RESL09) | Sep 24, 2025 |
| K243407 | Forcyte Medical | Forcyte Autograft Harvest Kit | Jul 29, 2025 |
| K244018 | Zhejiang Curaway Medical Technology Co | Disposable Biopsy Needle | Jul 22, 2025 |
| K243296 | Carbon (Shenzhen) Medical Device Co | Disposable Biopsy Needle | Jul 11, 2025 |
| K250032 | Bard Peripheral Vascular | Marquee Disposable Core Biopsy Instrument and Instrument Kit | Jul 10, 2025 |
| K243886 | Inrad | ExpressCore Biopsy Device | Apr 29, 2025 |
| K243945 | Surgentec | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | Apr 24, 2025 |
| K242128 | Xaga Surgical | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsv | Feb 27, 2025 |
| K242322 | Zhejiang Curaway Medical Technology Co | Bone Marrow Biopsy Needle | Jan 24, 2025 |
| K241793 | Zhejiang Curaway Medical Technology Co | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposa | Jan 24, 2025 |
| K242228 | Triopsy Medical | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy | Jan 10, 2025 |
| K243095 | Devicor Medical Products | Mammotome AutoCore Single Insertion Core Biopsy System | Oct 29, 2024 |