510(k) K203177

Sterisystem Dry-Base Instrument Tray by O&M Halyard, Inc. — Product Code KCT

K203177 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "Sterisystem Dry-Base Instrument Tray". The FDA issued a decision of Substantially Equivalent on January 2, 2022. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. O&M Halyard, Inc. has at least 10 other 510(k) clearances on record.