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FDA 510(k)

VMCore Biopsy Needle

K-Number: K201650 · 2021-01-15

ApplicantUro-1, Inc.
Decision Date2021-01-15
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VMCore Biopsy Needle is a medical device manufactured by Uro-1, Inc.. It received FDA 510(k) clearance on 2021-01-15 under approval number K201650. 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 VMCore Biopsy Needle?

VMCore Biopsy Needle is a medical device that received FDA 510(k) clearance on 2021-01-15. It is manufactured by Uro-1, Inc.. The 510(k) number is K201650.

When was VMCore Biopsy Needle approved by the FDA?

VMCore Biopsy Needle received FDA 510(k) clearance on 2021-01-15, under approval number K201650.

What company makes VMCore Biopsy Needle?

VMCore Biopsy Needle is manufactured by Uro-1, Inc..

What is the FDA product code for VMCore Biopsy Needle?

The FDA product code for VMCore Biopsy Needle is KNW.

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Other Devices by Uro-1, Inc.

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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

View on FDA Database →

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

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