Home › Device types › KNW
Instrument, Biopsy
FDA product code KNW · Class 2 · Gastroenterology, Urology
5,703
Registered devices
24,817
Adverse events
107
Recalls
365
510(k) clearances
Devices with this code
MaxiCell™ Biopsy Needle with Echogenic Tip — ARGON MEDICAL DEVICES, INC.M-Biopsy — Mermaid Medical A/SCuraway — Zhejiang CuraWay Medical Technology Co., Ltd.EnCor EnCompass™ — Bard Peripheral Vascular, Inc.RANR-1115N5T — RANFAC CORP.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.SureCore Semi-automatic Disposable Biopsy Needle — Canyon Medical Inc.M Biopsy Automatic Disposable Biopsy Needle — Canyon Medical Inc.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.M Biopsy Automatic Disposable Biopsy Needle — Canyon Medical Inc.BIOPSYBELL SRL — BIOPSYBELL SRLCo-Axial Introducer Needle — ARGON MEDICAL DEVICES, INC.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.Biopsybell — BIOPSYBELL SRLEstacore-Pro Automatic Biopsy Needle — GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIUNIVERSAL — MEDAX SRL UNIPERSONALEAchieve® — Merit Medical Systems, Inc.MEDBONE — MEDAX SRL UNIPERSONALECuraway — Zhejiang CuraWay Medical Technology Co., Ltd.Westcott Biopsy Needle with Echogenic Tip — ARGON MEDICAL DEVICES, INC.Vescut Automatic Biopsy Needle w/coaxial — GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETISpirotome Cervicore — BionciseTru-Cut® — Merit Medical Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-20 | Bard Peripheral Vascular Inc | Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pre |
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2025-12-15 | Hologic, Inc | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
| 2025-01-15 | Hologic, Inc | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. |
| 2024-09-30 | Bard Peripheral Vascular Inc | Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the |
| 2024-07-02 | Argon Medical Devices, Inc | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of |
| 2023-11-08 | Bard Peripheral Vascular Inc | The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed |
| 2023-08-10 | Bard Peripheral Vascular Inc | Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohib |
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