510(k) Report

Devices descending from K234050

2 later devices reach HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…O&M Halyard, Inc.20260—
+1K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…O&M Halyard, Inc.20260—