Disposable Automatic Core Biopsy Instrument

FDA 510(k) K212284 · Suzhou Leapmed Healthcare Corporation

Substantially Equivalent

510(k) numberK212284

Submission

Device name
Disposable Automatic Core Biopsy Instrument
Applicant
Suzhou Leapmed Healthcare Corporation
Suzhou, CN
Received
July 21, 2021
Decision date
November 10, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNW – Instrument, Biopsy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KNW

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K260517Automatic Core Biopsy InstrumentKNW · Traditional Zhejiang Curaway Medical Technology Co., Ltd.08/28/2026SE
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K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special Hologic, Inc.08/12/2026SE
K260572Marrow MarxmanKNW · Traditional Medimetrix, LLC08/04/2026SE
K261196Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special Promisemed Hangzhou Meditech Co., Ltd.05/12/2026SE
K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional Devicor Medical Products, Inc.03/04/2026SE
K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional Argon Medical Devices, Inc.02/23/2026SE
K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemKNW · Traditional Bard Peripheral Vascular, Inc.12/12/2025SE
K252183Resitu Slider 09 (RESL09)KNW · Traditional Resitu Medical AB09/24/2025SE
K243407Forcyte Autograft Harvest KitKNW · Traditional Forcyte Medical, LLC07/29/2025SE

More from Forcyte Medical, LLC

510(k)DeviceDecision
K212822Disposable Coaxial Biopsy NeedleFCG · Traditional 07/06/2022SE
K212820Disposable Semi Automatic Biopsy InstrumentKNW · Traditional 07/06/2022SE
K212819Disposable Biopsy Refill NeedleFCG · Traditional 07/06/2022SE

Questions and answers

When was Disposable Automatic Core Biopsy Instrument cleared by the FDA?

Disposable Automatic Core Biopsy Instrument (K212284) received a 510(k) decision of Substantially Equivalent on November 10, 2021, 112 days after the submission was received.

What is the product code of K212284?

The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.