FDA 510(k)

Perpak Sterilization Tyvek Pouch

K-Number: K241123 · 2024-09-18

Decision Date2024-09-18

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Perpak Sterilization Tyvek Pouch is a medical device manufactured by Km Corp.. It received FDA 510(k) clearance on 2024-09-18 under approval number K241123. 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 Perpak Sterilization Tyvek Pouch?

Perpak Sterilization Tyvek Pouch is a medical device that received FDA 510(k) clearance on 2024-09-18. It is manufactured by Km Corp.. The 510(k) number is K241123.

When was Perpak Sterilization Tyvek Pouch approved by the FDA?

Perpak Sterilization Tyvek Pouch received FDA 510(k) clearance on 2024-09-18, under approval number K241123.

What company makes Perpak Sterilization Tyvek Pouch?

Perpak Sterilization Tyvek Pouch is manufactured by Km Corp..

What is the FDA product code for Perpak Sterilization Tyvek Pouch?

The FDA product code for Perpak Sterilization Tyvek Pouch is FRG.

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.