FDA 510(k)

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM

Numéro K : K233294 · 2024-06-18

DemandeurItp Innovative Tomography Products GmbH

Date de décision2024-06-18

Code produitKNW

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is the device name listed in this FDA 510(k) record. The listed applicant is Itp Innovative Tomography Products GmbH. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K233294. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Itp Innovative Tomography Products GmbH. The 510(k) number is K233294.

When did Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM receive FDA 510(k) clearance?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM received FDA 510(k) clearance on 2024-06-18, under 510(k) number K233294.

Who is the listed applicant for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

The FDA 510(k) record lists Itp Innovative Tomography Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

The FDA product code for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is KNW.

Essais cliniques associés

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Autres dossiers indiquant Itp Innovative Tomography Products GmbH en tant que demandeur

K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)

Dispositifs connexes (Code : KNW)

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed 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.

Source officielle

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