FDA 510(k)

Transem and EchoGen Embryo Transfer Catheters

N.º K: K161547 · 2017-03-09

Fecha de decisión2017-03-09

Código de productoMQF

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Transem and EchoGen Embryo Transfer Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S. It received FDA 510(k) clearance on 2017-03-09 under 510(k) number K161547. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Transem and EchoGen Embryo Transfer Catheters?

Transem and EchoGen Embryo Transfer Catheters is a medical device that received FDA 510(k) clearance on 2017-03-09. The listed applicant is Origio A/S. The 510(k) number is K161547.

When did Transem and EchoGen Embryo Transfer Catheters receive FDA 510(k) clearance?

Transem and EchoGen Embryo Transfer Catheters received FDA 510(k) clearance on 2017-03-09, under 510(k) number K161547.

Who is the listed applicant for Transem and EchoGen Embryo Transfer Catheters?

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

What is the FDA product code for Transem and EchoGen Embryo Transfer Catheters?

The FDA product code for Transem and EchoGen Embryo Transfer Catheters is MQF.

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Otros registros que enlistan a Origio A/S como solicitante

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Dispositivos relacionados (Código: MQF)

K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)Guangzhou Hehong Biotech Co., Ltd.K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)Vitrolife Sweden AB K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)Shenzhen Vitavitro Biotech Co., Ltd.K231730FemaSeed Intratubal InseminationFemasys, Inc.K220010Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd.K200248Catéteres de Transferencia de Embriones Allwin (ETC), Estiletes y Obturadores Suaves Allwin ETC, yAllwin Medical Devices, Inc.

Fuente oficial

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