FDA 510(k)

allFlex Ureteral Catheters, Krait Ureteral Catheters

N.º K: K220730 · 2022-10-13

Fecha de decisión2022-10-13

Código de productoKOD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Allwin Medical Devices, Inc. como solicitante

K220781Conjunto de Dilatadores Ureterales ARMADA, Dilatador Paso a Paso Nottingham ARMADA, Conjuntos de Dilatadores Renales Amplatz ARMADA, Dilatador Renal ARMADA, Manguito Amplatz Glider, Dilatador Renal ARMADA con Manguito Amplatz, Conjunto de Dilatadores Fasciales, Manguito Introducción, Catéter Introducción K203626SureStrip Vitrification Straw, SureLock Vitrification Straw K200248Catéteres de Transferencia de Embriones Allwin (ETC), Estiletes y Obturadores Suaves Allwin ETC, y 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 K190590Needles de Recolección de Ovum Allwin (Ace Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, Ace-FL Single Lumen Ovum Pickup Needle con Línea de Limpieza, Ace-M Manual Single Lumen Ovum Pickup Needle)K190522Catéteres de Inseminación Intrauterina Allwin (INSEMINA y Catéter de Inseminación Intrauterina de Pico Abierto INSEMINA, CURVED y CURVED de Pico Abierto, TRACKABLE y TRACKABLE de Pico Abierto, FLEXI y FLEXI de Pico Abierto, CATÉTER DE INSEMINACIÓN INTRAUTERINA STUMPY)

Ver todos los 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.K181144Catheter de Ureteral con Pico AnguladoCook Incorporated

Fuente oficial

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