FDA 510(k)

ENDOGATOR™ Hybrid Irrigation Tubing

Número K: K231418 · 2023-08-14

Data da decisão2023-08-14

Código do produtoOCX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENDOGATOR™ Hybrid Irrigation Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Medivators. It received FDA 510(k) clearance on 2023-08-14 under 510(k) number K231418. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ENDOGATOR™ Hybrid Irrigation Tubing?

ENDOGATOR™ Hybrid Irrigation Tubing is a medical device that received FDA 510(k) clearance on 2023-08-14. The listed applicant is Medivators. The 510(k) number is K231418.

When did ENDOGATOR™ Hybrid Irrigation Tubing receive FDA 510(k) clearance?

ENDOGATOR™ Hybrid Irrigation Tubing received FDA 510(k) clearance on 2023-08-14, under 510(k) number K231418.

Who is the listed applicant for ENDOGATOR™ Hybrid Irrigation Tubing?

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

What is the FDA product code for ENDOGATOR™ Hybrid Irrigation Tubing?

The FDA product code for ENDOGATOR™ Hybrid Irrigation Tubing is OCX.

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