FDA 510(k)

allFlex Ureteral Catheters, Krait Ureteral Catheters

Número K: K220730 · 2022-10-13

Data da decisão2022-10-13

Código do produtoKOD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

allFlex Ureteral Catheters, Krait Ureteral Catheters 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 2022-10-13 under 510(k) number K220730. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the allFlex Ureteral Catheters, Krait Ureteral Catheters?

allFlex Ureteral Catheters, Krait Ureteral Catheters is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K220730.

When did allFlex Ureteral Catheters, Krait Ureteral Catheters receive FDA 510(k) clearance?

allFlex Ureteral Catheters, Krait Ureteral Catheters received FDA 510(k) clearance on 2022-10-13, under 510(k) number K220730.

Who is the listed applicant for allFlex Ureteral Catheters, Krait Ureteral Catheters?

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 allFlex Ureteral Catheters, Krait Ureteral Catheters?

The FDA product code for allFlex Ureteral Catheters, Krait Ureteral Catheters is KOD.

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

K220781Conjunto 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 K203626SureStrip Vitrification Straw, SureLock Vitrification Straw K200248Cateteres de Transferência de Embrião Allwin (ETC), Estiletes e Obturadores Macios Allwin ETC K190659Ureteral 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 Tip K190590Agulhas 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: KOD)

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.K181144Cáteter Ureteral com Ponta AnguladaCook Incorporated

Fonte oficial

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