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.
Summary
Zhejiang Curaway Medical Technology filed an Automatic Core Biopsy Instrument under product code KNW, biopsy instruments. The device name is generic, and the record gives no model number.
Class II, 21 CFR 876.1075. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Curaway filed from Hangzhou, China. The decision came 192 calendar days after receipt (February 17 to August 28, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Zhejiang Curaway Medical Technology Co., Ltd.
- Product code
- Product 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.