510(k) K231604

Instrument Case by Cochlear Americas — Product Code KCT

K231604 is an FDA 510(k) premarket notification submitted by Cochlear Americas for the device "Instrument Case". The FDA issued a decision of Substantially Equivalent on August 24, 2023. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Cochlear Americas has at least 10 other 510(k) clearances on record.