FDA 510(k)

Dornier MAGELLAN Ureteral Access Sheath

N.º K: K201815 · 2020-11-20

SolicitanteDornier Medtech America, Inc.

Fecha de decisión2020-11-20

Código de productoFED

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dornier MAGELLAN Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K201815. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dornier MAGELLAN Ureteral Access Sheath?

Dornier MAGELLAN Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K201815.

When did Dornier MAGELLAN Ureteral Access Sheath receive FDA 510(k) clearance?

Dornier MAGELLAN Ureteral Access Sheath received FDA 510(k) clearance on 2020-11-20, under 510(k) number K201815.

Who is the listed applicant for Dornier MAGELLAN Ureteral Access Sheath?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dornier MAGELLAN Ureteral Access Sheath?

The FDA product code for Dornier MAGELLAN Ureteral Access Sheath is FED.

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Dispositivos relacionados (Código: FED)

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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