FDA 510(k)

SureStrip Vitrification Straw, SureLock Vitrification Straw

N.º K: K203626 · 2021-06-04

Fecha de decisión2021-06-04

Código de productoMQK

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

SureStrip Vitrification Straw, SureLock Vitrification Straw 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 2021-06-04 under 510(k) number K203626. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SureStrip Vitrification Straw, SureLock Vitrification Straw?

SureStrip Vitrification Straw, SureLock Vitrification Straw is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K203626.

When did SureStrip Vitrification Straw, SureLock Vitrification Straw receive FDA 510(k) clearance?

SureStrip Vitrification Straw, SureLock Vitrification Straw received FDA 510(k) clearance on 2021-06-04, under 510(k) number K203626.

Who is the listed applicant for SureStrip Vitrification Straw, SureLock Vitrification Straw?

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 SureStrip Vitrification Straw, SureLock Vitrification Straw?

The FDA product code for SureStrip Vitrification Straw, SureLock Vitrification Straw is MQK.

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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 K220730allFlex Ureteral Catheters, Krait Ureteral Catheters 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 →

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Fuente oficial

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