FDA 510(k)

Synvitro Hyadase

N.º K: K200680 · 2020-07-17

SolicitanteOrigio A/S, A Coopersurgical Company

Fecha de decisión2020-07-17

Código de productoMQL

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Synvitro Hyadase is the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S, A Coopersurgical Company. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K200680. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Synvitro Hyadase?

Synvitro Hyadase is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Origio A/S, A Coopersurgical Company. The 510(k) number is K200680.

When did Synvitro Hyadase receive FDA 510(k) clearance?

Synvitro Hyadase received FDA 510(k) clearance on 2020-07-17, under 510(k) number K200680.

Who is the listed applicant for Synvitro Hyadase?

The FDA 510(k) record lists Origio A/S, A Coopersurgical Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synvitro Hyadase?

The FDA product code for Synvitro Hyadase is MQL.

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: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

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.