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FDA 510(k)

PRO-LITE Sterilization Tray

K-Number: K231501 · 2023-08-07

Decision Date2023-08-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-LITE Sterilization Tray is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2023-08-07 under approval number K231501. 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 PRO-LITE Sterilization Tray?

PRO-LITE Sterilization Tray is a medical device that received FDA 510(k) clearance on 2023-08-07. It is manufactured by STERIS Corporation. The 510(k) number is K231501.

When was PRO-LITE Sterilization Tray approved by the FDA?

PRO-LITE Sterilization Tray received FDA 510(k) clearance on 2023-08-07, under approval number K231501.

What company makes PRO-LITE Sterilization Tray?

PRO-LITE Sterilization Tray is manufactured by STERIS Corporation.

What is the FDA product code for PRO-LITE Sterilization Tray?

The FDA product code for PRO-LITE Sterilization Tray is KCT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.