FDA 510(k)

SteriBest® Sterilization Tray System

Número K: K253187 · 2026-06-18

Data da decisão2026-06-18

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SteriBest® Sterilization Tray System is the device name listed in this FDA 510(k) record. The listed applicant is Mastel Surgical. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253187. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SteriBest® Sterilization Tray System?

SteriBest® Sterilization Tray System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Mastel Surgical. The 510(k) number is K253187.

When did SteriBest® Sterilization Tray System receive FDA 510(k) clearance?

SteriBest® Sterilization Tray System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253187.

Who is the listed applicant for SteriBest® Sterilization Tray System?

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

What is the FDA product code for SteriBest® Sterilization Tray System?

The FDA product code for SteriBest® Sterilization Tray System is KCT.

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Dispositivos Relacionados (Código: KCT)

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Fonte oficial

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