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FDA 510(k)

ONE TRAY® Sealed Sterilization Container System

N.º K: K250029 · 2025-05-01

SolicitanteInnovative Sterilization Technologies
Fecha de decisión2025-05-01
Código de productoKCT
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

ONE TRAY® Sealed Sterilization Container System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Sterilization Technologies. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K250029. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ONE TRAY® Sealed Sterilization Container System?

ONE TRAY® Sealed Sterilization Container System is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Innovative Sterilization Technologies. The 510(k) number is K250029.

When did ONE TRAY® Sealed Sterilization Container System receive FDA 510(k) clearance?

ONE TRAY® Sealed Sterilization Container System received FDA 510(k) clearance on 2025-05-01, under 510(k) number K250029.

Who is the listed applicant for ONE TRAY® Sealed Sterilization Container System?

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

What is the FDA product code for ONE TRAY® Sealed Sterilization Container System?

The FDA product code for ONE TRAY® Sealed Sterilization Container System is KCT.

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Dispositivos relacionados (Código: KCT)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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