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FDA 510(k)

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

K-Number: K242208 · 2024-10-07

ApplicantPrimed Medical Products, Inc.
Decision Date2024-10-07
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2024-10-07 under 510(k) number K242208. 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 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K242208.

When did PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) receive FDA 510(k) clearance?

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) received FDA 510(k) clearance on 2024-10-07, under 510(k) number K242208.

Who is the listed applicant for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

The FDA 510(k) record lists Primed Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

The FDA product code for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) is FRG.

Other records listing Primed Medical Products, 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.

K252964PRIMED Surgical and Procedure MasksK240286PRIMED Surgical Masks and PRIMED Procedure MasksK233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K213427PRIMED Pediatric FacemaskK160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

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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