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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 a medical device manufactured by Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2021-11-10 under approval 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. It is manufactured by Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212284.

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

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

What company makes Disposable Automatic Core Biopsy Instrument?

Disposable Automatic Core Biopsy Instrument is manufactured by Suzhou Leapmed Healthcare Corporation.

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 Devices by Suzhou Leapmed Healthcare Corporation

K212819Disposable Biopsy Refill Needle K212822Disposable Coaxial Biopsy Needle K212820Disposable Semi Automatic Biopsy Instrument

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, 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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