FDA 510(k)

ENDOGATOR Hybrid Irrigation Tubing

K-Number: K231418 · 2023-08-14

Decision Date2023-08-14

Product CodeOCX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENDOGATOR Hybrid Irrigation Tubing is a medical device manufactured by Medivators. It received FDA 510(k) clearance on 2023-08-14 under approval number K231418. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Medivators. The 510(k) number is K231418.

When was ENDOGATOR Hybrid Irrigation Tubing approved by the FDA?

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

What company makes ENDOGATOR Hybrid Irrigation Tubing?

ENDOGATOR Hybrid Irrigation Tubing is manufactured by Medivators.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.