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FDA 510(k)

HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)

K-Number: K240330 · 2024-08-07

ApplicantO&M Halyard, Inc.
Decision Date2024-08-07
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2024-08-07 under 510(k) number K240330. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)?

HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) is a medical device that received FDA 510(k) clearance on 2024-08-07. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K240330.

When did HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) receive FDA 510(k) clearance?

HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) received FDA 510(k) clearance on 2024-08-07, under 510(k) number K240330.

Who is the listed applicant for HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)?

The FDA 510(k) record lists O&M Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)?

The FDA product code for HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) is FRG.

Other records listing O&M Halyard, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesK261897HALYARD* 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* TechnologyK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapK251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorK252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsK243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

View all 26 devices →

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261897HALYARD* 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* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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