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FDA 510(k)

SUREcore Prime Biopsy Instrument

K-Number: K230646 · 2023-11-29

ApplicantUro-1 Medical, Inc.
Decision Date2023-11-29
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUREcore Prime Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Uro-1 Medical, Inc.. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K230646. 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 SUREcore Prime Biopsy Instrument?

SUREcore Prime Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Uro-1 Medical, Inc.. The 510(k) number is K230646.

When did SUREcore Prime Biopsy Instrument receive FDA 510(k) clearance?

SUREcore Prime Biopsy Instrument received FDA 510(k) clearance on 2023-11-29, under 510(k) number K230646.

Who is the listed applicant for SUREcore Prime Biopsy Instrument?

The FDA 510(k) record lists Uro-1 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUREcore Prime Biopsy Instrument?

The FDA product code for SUREcore Prime Biopsy Instrument 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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