FDA 510(k)

BioStar Single Use Transbronchial Aspiration Needle

Número K: K232038 · 2024-04-26

Data da decisão2024-04-26

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioStar Single Use Transbronchial Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Broncus Medical, Inc.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K232038. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioStar Single Use Transbronchial Aspiration Needle?

BioStar Single Use Transbronchial Aspiration Needle is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Broncus Medical, Inc.. The 510(k) number is K232038.

When did BioStar Single Use Transbronchial Aspiration Needle receive FDA 510(k) clearance?

BioStar Single Use Transbronchial Aspiration Needle received FDA 510(k) clearance on 2024-04-26, under 510(k) number K232038.

Who is the listed applicant for BioStar Single Use Transbronchial Aspiration Needle?

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

What is the FDA product code for BioStar Single Use Transbronchial Aspiration Needle?

The FDA product code for BioStar Single Use Transbronchial Aspiration Needle is EOQ.

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Outros registros que listam Broncus Medical, Inc. como candidato(a)

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Dispositivos Relacionados (Código: EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Fonte oficial

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