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The Tracker / August 2026 / K260517

510(k) cleared

Automatic Core Biopsy Instrument

Zhejiang Curaway Medical Technology Co., Ltd. · Aug 28, 2026 · K260517

FDA cleared the Automatic Core Biopsy Instrument from Zhejiang Curaway Medical Technology Co., Ltd. on Aug 28, 2026 under K260517, a traditional 510(k). The device falls under product code KNW, Instrument, Biopsy, regulated at 21 CFR 876.1075 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 17, 2026. The decision came 192 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zhejiang Curaway Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260517?

K260517 is the FDA 510(k) for Automatic Core Biopsy Instrument, submitted by Zhejiang Curaway Medical Technology Co., Ltd.. FDA's decision date was Aug 28, 2026, under product code KNW (Instrument, Biopsy).

Who makes the Automatic Core Biopsy Instrument?

Zhejiang Curaway Medical Technology Co., Ltd., based in Hangzhou, is the applicant of record for K260517.

How long did the K260517 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Aug 28, 2026, 192 days later.

← All decisions in August 2026