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FDA 510(k)

PAL Sterilization Case

K-Number: K243589 · 2025-06-20

Decision Date2025-06-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PAL Sterilization Case is a medical device manufactured by Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2025-06-20 under approval number K243589. 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 PAL Sterilization Case?

PAL Sterilization Case is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Microaire Surgical Instruments, LLC. The 510(k) number is K243589.

When was PAL Sterilization Case approved by the FDA?

PAL Sterilization Case received FDA 510(k) clearance on 2025-06-20, under approval number K243589.

What company makes PAL Sterilization Case?

PAL Sterilization Case is manufactured by Microaire Surgical Instruments, LLC.

What is the FDA product code for PAL Sterilization Case?

The FDA product code for PAL Sterilization Case is KCT.

Other Devices by Microaire Surgical Instruments, LLC

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Related Devices (Code: KCT)

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.