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FDA 510(k)

Disposable Semi Automatic Biopsy Instrument

K-Number: K212820 · 2022-07-06

ApplicantSuzhou Leapmed Healthcare Corporation
Decision Date2022-07-06
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Semi Automatic Biopsy Instrument is a medical device manufactured by Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2022-07-06 under approval number K212820. 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 Semi Automatic Biopsy Instrument?

Disposable Semi Automatic Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212820.

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

Disposable Semi Automatic Biopsy Instrument received FDA 510(k) clearance on 2022-07-06, under approval number K212820.

What company makes Disposable Semi Automatic Biopsy Instrument?

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

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

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

Other Devices by Suzhou Leapmed Healthcare Corporation

K212284Disposable Automatic Core Biopsy Instrument K212819Disposable Biopsy Refill Needle K212822Disposable Coaxial Biopsy Needle

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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