FDA 510(k)

Wellead Endoscopic Seal

Número K: K211814 · 2022-01-14

Data da decisão2022-01-14

Código do produtoODC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wellead Endoscopic Seal 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 2022-01-14 under 510(k) number K211814. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wellead Endoscopic Seal?

Wellead Endoscopic Seal is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K211814.

When did Wellead Endoscopic Seal receive FDA 510(k) clearance?

Wellead Endoscopic Seal received FDA 510(k) clearance on 2022-01-14, under 510(k) number K211814.

Who is the listed applicant for Wellead Endoscopic Seal?

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 Wellead Endoscopic Seal?

The FDA product code for Wellead Endoscopic Seal is ODC.

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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 K202134Well Lead All Silicone Foley Catheter with Temperature Sensor K203119ClearPetra Suction-Evacuation Sheath

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Fonte oficial

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