FDA 510(k)

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

K-Number: K242208 · 2024-10-07

Decision Date2024-10-07

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

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

When was PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) approved by the FDA?

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

What company makes PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) is manufactured by Primed Medical Products, Inc..

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 Devices by Primed Medical Products, Inc.

K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3) K213427PRIMED Pediatric Facemask K240286PRIMED Surgical Masks and PRIMED Procedure Masks K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) K252964PRIMED Surgical and Procedure Masks

Related Devices (Code: FRG)

K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation K152564Gemini Sterilization WrapMedline Industries, Inc.

Official Source

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