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FDA 510(k)

PAL Sterilization Case

K-Number: K243589 · 2025-06-20

ApplicantMicroaire Surgical Instruments, LLC
Decision Date2025-06-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PAL Sterilization Case is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2025-06-20 under 510(k) 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. The listed applicant is Microaire Surgical Instruments, LLC. The 510(k) number is K243589.

When did PAL Sterilization Case receive FDA 510(k) clearance?

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

Who is the listed applicant for PAL Sterilization Case?

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

What is the FDA product code for PAL Sterilization Case?

The FDA product code for PAL Sterilization Case is KCT.

Other records listing Microaire Surgical Instruments, LLC as applicant

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.

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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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