510(k) clearances

Automatic Core Biopsy Instrument

Zhejiang Curaway Medical Technology Co., Ltd. · Gastroenterology, Urology

K260517Substantially EquivalentTraditionalKNW
Open FDA's page for this record
Third party flag
N
City
Hangzhou
Advisory committee description
Gastroenterology, Urology
Address 1
Rm. 106, Bldg. 1, # 600, 21st Ave., Baiyang Sub-District, Qi
Statement or summary
Summary
Product code
KNW
Zip code
310018
Applicant
Zhejiang Curaway Medical Technology Co., Ltd.
Decision date
2026-08-28
Decision code
SESE
Country code
CN
Device name
Automatic Core Biopsy Instrument
Advisory committee
GU
Contact
Yin Li
K number
K260517
Date received
2026-02-17
Review advisory committee
SU
Postal code
310018
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Instrument, Biopsy
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1075
Device class
2
Registration number
3018507299, 1224960, 3021023752, 3005580113, 3017210488, 3007137598, 1219114, 1526711, 3030626857, 3008262715, 3038611181, 3010097171, 1835568, 9617592, 3010220595, 3016844398, 3006849754, 2029275, 3004111573, 3010041511, 1644312, 9617616, 1820334, 3012447612, 2648623, 3004122598, 3004774118, 3030733800, 3015980719, 1419411, 1643817, 3006788678, 3033858858, 2020394, 1048735, 1319660, 1450662, 3008773560, 3015309643, 3012470322 +166 more
FEI number
3018507299, 3021023752, 3007019930, 3005580113, 3017210488, 3007137598, 1219114, 1526711, 3030626857, 3008262715, 3038611181, 3010097171, 3003056094, 3010220595, 3016844398, 3000215205, 3006849754, 3010041511, 3004111573, 3002827704, 3002808445, 3012447612, 1820334, 2648623, 3004122598, 3030733800, 3015980719, 1643817, 3006788678, 3033858858, 2020394, 1048735, 1450662, 3008773560, 3015309643, 3012470322, 3008002452, 3012495575, 3007513241, 3010082909 +166 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.