510(k) K243589

PAL Sterilization Case by Microaire Surgical Instruments, LLC — Product Code KCT

K243589 is an FDA 510(k) premarket notification submitted by Microaire Surgical Instruments, LLC for the device "PAL Sterilization Case". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Microaire Surgical Instruments, LLC has at least 10 other 510(k) clearances on record.