510(k) K234050

HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap by O&M Halyard, Inc. — Product Code FRG

K234050 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on September 16, 2024. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. O&M Halyard, Inc. has at least 10 other 510(k) clearances on record.