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FDA 510(k)

APrioCore Plus

K-Number: K193268 · 2020-02-27

ApplicantApriomed AB
Decision Date2020-02-27
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

APrioCore Plus is the device name listed in this FDA 510(k) record. The listed applicant is Apriomed AB. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K193268. 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 APrioCore Plus?

APrioCore Plus is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Apriomed AB. The 510(k) number is K193268.

When did APrioCore Plus receive FDA 510(k) clearance?

APrioCore Plus received FDA 510(k) clearance on 2020-02-27, under 510(k) number K193268.

Who is the listed applicant for APrioCore Plus?

The FDA 510(k) record lists Apriomed AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APrioCore Plus?

The FDA product code for APrioCore Plus is KNW.

Other records listing Apriomed AB 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.

K181756Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial 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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