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FDA 510(k)

Conjunto de Dilatador Ureteral ARMADA, Dilatador de Um Passo Nottingham ARMADA, Conjuntos de Dilatador Renal Amplatz ARMADA, Dilatador Renal ARMADA, Casula Amplatz, Dilatador Renal ARMADA com Casula Amplatz, Conjunto de Dilatador Fascial, Cateter Introduzidor, Cateter Introduzidor

Número K: K220781 · 2023-05-05

RequerenteAllwin Medical Devices, Inc.
Data da decisão2023-05-05
Código do produtoEZN
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K220781. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter?

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K220781.

When did ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter receive FDA 510(k) clearance?

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter received FDA 510(k) clearance on 2023-05-05, under 510(k) number K220781.

Who is the listed applicant for ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter?

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

What is the FDA product code for ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter?

The FDA product code for ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter is EZN.

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

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K220730allFlex Ureteral Catheters, Krait Ureteral CathetersK203626SureStrip Vitrification Straw, SureLock Vitrification StrawK200248Cateteres de Transferência de Embrião Allwin (ETC), Estiletes e Obturadores Macios Allwin ETCK190659Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed TipK190590Agulhas de Retirada de Ovário Allwin (Agulha de Retirada de Ovário de Único Lumeno ACE, Agulha de Retirada de Ovário de Duplo Lumeno OVUMPICK, Agulha de Retirada de Ovário de Único Lumeno com Linha de Limpeza ACE-FL, Agulha de Retirada de Ovário Manual de Único Lumeno ACE-M)K190522Cateteres de Inseminação Intrauterina Allwin (INSEMINA e Cateter de Inseminação Intrauterina com Ponta Aberta INSEMINA, CURVED e CURVED com Ponta Aberta, TRACKABLE e TRACKABLE com Ponta Aberta, FLEXI e FLEXI com Ponta Aberta, CATETER DE INSEMINAÇÃO INTRAUTERINA STUMPY)

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: EZN)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook IncorporatedK180756Safety Wire Guide IntroducerCook IncorporatedK180028Cook 810 Set, Desilets-Hoffman Introducer SetCook Incorporated

Fonte oficial

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