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FDA 510(k)

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

K-Number: K222440 · 2022-09-09

ApplicantSteris
Decision Date2022-09-09
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays is a medical device manufactured by Steris. It received FDA 510(k) clearance on 2022-09-09 under approval number K222440. 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 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays?

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays is a medical device that received FDA 510(k) clearance on 2022-09-09. It is manufactured by Steris. The 510(k) number is K222440.

When was Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays approved by the FDA?

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays received FDA 510(k) clearance on 2022-09-09, under approval number K222440.

What company makes Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays?

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays is manufactured by Steris.

What is the FDA product code for Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays?

The FDA product code for Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays is FRG.

Other Devices by Steris

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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

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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