HALYARD? ONE-STEP? Sterilization Wrap, HALYARD? QUICK CHECK? Sterilization Wrap, HALYARD? SEQUENTIAL Sterilization Wrap and HALYARD? SMART-FOLD? Sterilization Wrap

About This 510(k) Submission

K234050 is an FDA 510(k) clearance for the HALYARD? ONE-STEP? Sterilization Wrap, HALYARD? QUICK CHECK? Sterilization Wrap, HALYARD? SEQUENTIAL Sterilization Wrap and HALYARD? SMART-FOLD? Sterilization Wrap, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on September 16, 2024, 270 days after receiving the submission on December 21, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.