FDA 510(k)

Well Lead Ureteral Access Sheath

Número K: K151084 · 2016-01-07

Data da decisão2016-01-07

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Well Lead Ureteral Access 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 2016-01-07 under 510(k) number K151084. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Well Lead Ureteral Access Sheath?

Well Lead Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K151084.

When did Well Lead Ureteral Access Sheath receive FDA 510(k) clearance?

Well Lead Ureteral Access Sheath received FDA 510(k) clearance on 2016-01-07, under 510(k) number K151084.

Who is the listed applicant for Well Lead Ureteral Access 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 Well Lead Ureteral Access Sheath?

The FDA product code for Well Lead Ureteral Access Sheath is FED.

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Outros registros que listam Well Lead Medical Co., Ltd. como candidato(a)

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.

Fonte oficial

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