Automatic Core Biopsy Instrument— 510(k) K260517
Substantially EquivalentZhejiang Curaway Medical Technology Co., Ltd.
FDA 510(k) clearance K260517 for Automatic Core Biopsy Instrument, Substantially Equivalent on 2026-08-28. Applicant: Zhejiang Curaway Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhejiang Curaway Medical Technology Co., Ltd.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code KNW
view all- K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System
- K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
- K260572 — Marrow Marxman
- K261196 — Promisemed VeriEcto Automatic Biopsy Needles
- K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 more
More clearances from Zhejiang Curaway Medical Technology Co., Ltd.
view all- K244018 — Disposable Biopsy Needle
- K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
- K242322 — Bone Marrow Biopsy Needle
- K240758 — Radiofrequency Generator System, Cura RF Electrode
- K232505 — Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.