Device Listing 1091267294

Listing Summary#

Listing key
1091267294
Premarket submission
K261897
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
Applicant
O&M Halyard, Inc.
Product code
FRG
Decision date
2026-07-02