510(k) K253454

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

K253454 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; HALYARD* SMART-FOLD* Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on May 18, 2026. 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.