FDA 510(k)

GCI Sterilization Wrappers

K-Number: K250321 · 2025-06-06

Decision Date2025-06-06

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

GCI Sterilization Wrappers is a medical device manufactured by George Courey, Inc.. It received FDA 510(k) clearance on 2025-06-06 under approval number K250321. 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 GCI Sterilization Wrappers?

GCI Sterilization Wrappers is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by George Courey, Inc.. The 510(k) number is K250321.

When was GCI Sterilization Wrappers approved by the FDA?

GCI Sterilization Wrappers received FDA 510(k) clearance on 2025-06-06, under approval number K250321.

What company makes GCI Sterilization Wrappers?

GCI Sterilization Wrappers is manufactured by George Courey, Inc..

What is the FDA product code for GCI Sterilization Wrappers?

The FDA product code for GCI Sterilization Wrappers is FRG.

Other Devices by George Courey, Inc.

K233571GCI Surgical Gown

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.