FDA 510(k)

SpermAlign Sperm Separation Device

N.º K: K232980 · 2024-03-14

Fecha de decisión2024-03-14

Código de productoMQK

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

SpermAlign Sperm Separation Device is the device name listed in this FDA 510(k) record. The listed applicant is Cytoswim, Ltd.. It received FDA 510(k) clearance on 2024-03-14 under 510(k) number K232980. 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 SpermAlign Sperm Separation Device?

SpermAlign Sperm Separation Device is a medical device that received FDA 510(k) clearance on 2024-03-14. The listed applicant is Cytoswim, Ltd.. The 510(k) number is K232980.

When did SpermAlign Sperm Separation Device receive FDA 510(k) clearance?

SpermAlign Sperm Separation Device received FDA 510(k) clearance on 2024-03-14, under 510(k) number K232980.

Who is the listed applicant for SpermAlign Sperm Separation Device?

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

What is the FDA product code for SpermAlign Sperm Separation Device?

The FDA product code for SpermAlign Sperm Separation Device is MQK.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: MQK)

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation K241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps K241341cryo-GO Vitrification DeviceFujifilm Irvine Scientific K240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K233177Nest VT Vitrification DeviceCook Incorporated

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.