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FDA 510(k)

ENDOGATOR™ Hybrid Irrigation Tubing

K-Number: K231418 · 2023-08-14

ApplicantMedivators
Decision Date2023-08-14
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Other records listing Medivators as applicant

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Related Devices (Code: OCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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