Cleared Traditional

K260517 - Automatic Core Biopsy Instrument

K260517 is an FDA 510(k) clearance for Automatic Core Biopsy Instrument, manufactured by Zhejiang Curaway Medical Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K260517 · Zhejiang Curaway Medical Technology Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2026
Decision
192d
Days
Class 2
Risk

K260517 is an FDA 510(k) clearance for the Automatic Core Biopsy Instrument. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Zhejiang Curaway Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 28, 2026 after a review of 192 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Curaway Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K260517

510(k) Number K260517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2026
Decision Date August 28, 2026
Days to Decision 192 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 115d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 255
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K260517.
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ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit)
K252795 · Argon Medical Devices, Inc. · Feb 2026