FDA 510(k)

ClearPetra Suction-Evacuation Sheath

N.º K: K161110 · 2016-10-12

Fecha de decisión2016-10-12

Código de productoFED

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ClearPetra Suction-Evacuation Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K161110. 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 ClearPetra Suction-Evacuation Sheath?

ClearPetra Suction-Evacuation Sheath is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K161110.

When did ClearPetra Suction-Evacuation Sheath receive FDA 510(k) clearance?

ClearPetra Suction-Evacuation Sheath received FDA 510(k) clearance on 2016-10-12, under 510(k) number K161110.

Who is the listed applicant for ClearPetra Suction-Evacuation Sheath?

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

What is the FDA product code for ClearPetra Suction-Evacuation Sheath?

The FDA product code for ClearPetra Suction-Evacuation Sheath is FED.

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Otros registros que enlistan a Well Lead Medical Co., Ltd. como solicitante

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact K220722PVC Hydrophilic Urethral Catheter K220036Wellead Ureteral Catheter K211543Wei Nasal Jet Tube K211814Wellead Endoscopic Seal K202134Well Lead All Silicone Foley Catheter with Temperature Sensor

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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

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