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FDA 510(k)

Disposable Automatic Core Biopsy Instrument

K-Number: K212284 · 2021-11-10

ApplicantSuzhou Leapmed Healthcare Corporation
Decision Date2021-11-10
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Automatic Core Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212284. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Automatic Core Biopsy Instrument?

Disposable Automatic Core Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212284.

When did Disposable Automatic Core Biopsy Instrument receive FDA 510(k) clearance?

Disposable Automatic Core Biopsy Instrument received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212284.

Who is the listed applicant for Disposable Automatic Core Biopsy Instrument?

The FDA 510(k) record lists Suzhou Leapmed Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Automatic Core Biopsy Instrument?

The FDA product code for Disposable Automatic Core Biopsy Instrument is KNW.

Other records listing Suzhou Leapmed Healthcare Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212822Disposable Coaxial Biopsy NeedleK212820Disposable Semi Automatic Biopsy InstrumentK212819Disposable Biopsy Refill Needle

Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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