ENDOGATOR Hybrid Irrigation Tubing— 510(k) K231418

Substantially Equivalent

Medivators

FDA 510(k) clearance K231418 for ENDOGATOR Hybrid Irrigation Tubing, Substantially Equivalent on 2023-08-14. Applicant: Medivators. Device class: 2.

Clearance details

Applicant: Medivators
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-05-16
Decision date: 2023-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.