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FDA 510(k)

SteriCUBE® Multiple Tray Sterilization Systems

K-Number: K222328 · 2022-09-28

ApplicantStericube, LLC
Decision Date2022-09-28
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteriCUBE® Multiple Tray Sterilization Systems is the device name listed in this FDA 510(k) record. The listed applicant is Stericube, LLC. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K222328. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SteriCUBE® Multiple Tray Sterilization Systems?

SteriCUBE® Multiple Tray Sterilization Systems is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Stericube, LLC. The 510(k) number is K222328.

When did SteriCUBE® Multiple Tray Sterilization Systems receive FDA 510(k) clearance?

SteriCUBE® Multiple Tray Sterilization Systems received FDA 510(k) clearance on 2022-09-28, under 510(k) number K222328.

Who is the listed applicant for SteriCUBE® Multiple Tray Sterilization Systems?

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

What is the FDA product code for SteriCUBE® Multiple Tray Sterilization Systems?

The FDA product code for SteriCUBE® Multiple Tray Sterilization Systems is KCT.

Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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