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FDA 510(k)

NovaCore Semi-Automatic Biopsy Instrument

K-Number: K213232 · 2022-07-01

ApplicantArgon Medical Devices
Decision Date2022-07-01
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NovaCore Semi-Automatic Biopsy Instrument is a medical device manufactured by Argon Medical Devices. It received FDA 510(k) clearance on 2022-07-01 under approval number K213232. 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 NovaCore Semi-Automatic Biopsy Instrument?

NovaCore Semi-Automatic Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Argon Medical Devices. The 510(k) number is K213232.

When was NovaCore Semi-Automatic Biopsy Instrument approved by the FDA?

NovaCore Semi-Automatic Biopsy Instrument received FDA 510(k) clearance on 2022-07-01, under approval number K213232.

What company makes NovaCore Semi-Automatic Biopsy Instrument?

NovaCore Semi-Automatic Biopsy Instrument is manufactured by Argon Medical Devices.

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

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

Other Devices by Argon Medical Devices

K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) K213002SCORPION Portal Vein Access Set K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters K230631Kodiak™ Dual Port Coaxial Introducer Kit

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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