510(k) clearance
Automatic Core Biopsy Instrument
- 510(k) number
- K260517
- Applicant
- Zhejiang Curaway Medical Technology Co., Ltd.
- Decision date
- Aug 28, 2026
- Date received
- Feb 17, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KNW
- Device type
- Instrument, Biopsy
- Device class
- Class II
- Regulation
- 21 CFR 876.1075
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Hangzhou, CN