510(k) K261897

HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology by O&M Halyard, Inc. — Product Code FRG

K261897 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology". The FDA issued a decision of Substantially Equivalent on July 2, 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.