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FDA 510(k)

NeoNavia Biopsy System

K-Number: K220595 · 2022-09-08

ApplicantNeodynamics AB
Decision Date2022-09-08
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NeoNavia Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Neodynamics AB. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K220595. 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 NeoNavia Biopsy System?

NeoNavia Biopsy System is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Neodynamics AB. The 510(k) number is K220595.

When did NeoNavia Biopsy System receive FDA 510(k) clearance?

NeoNavia Biopsy System received FDA 510(k) clearance on 2022-09-08, under 510(k) number K220595.

Who is the listed applicant for NeoNavia Biopsy System?

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

What is the FDA product code for NeoNavia Biopsy System?

The FDA product code for NeoNavia Biopsy System is KNW.

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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