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Endo Smart Bottle, Rinse And Insufflation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140753

by Medivators

Identifiers

510(k) Number
K140753 FDA 510(k)
FDA Product Code
OCX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Endo Smart Bottle, Rinse And Insufflation System by Medivators — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medivators

Sources (1)

  • FDA 510(k) K140753 24 fields · synced Jun 18, 2026