Decision Date2022-07-27
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K214007. 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 ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. The 510(k) number is K214007.
When did HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap receive FDA 510(k) clearance?
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap received FDA 510(k) clearance on 2022-07-27, under 510(k) number K214007.
Who is the listed applicant for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?
The FDA 510(k) record lists Owens & Minor (O&M) Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?
The FDA product code for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is FRG.
Other records listing Owens & Minor (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.
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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.
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.