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FDA 510(k)

Vis-U-All Low Temperature Sterilization Pouch/Tubing

K-Number: K183297 · 2019-01-03

ApplicantSTERIS Corporation
Decision Date2019-01-03
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vis-U-All Low Temperature Sterilization Pouch/Tubing is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2019-01-03 under approval number K183297. 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 Pouch/Tubing?

Vis-U-All Low Temperature Sterilization Pouch/Tubing is a medical device that received FDA 510(k) clearance on 2019-01-03. It is manufactured by STERIS Corporation. The 510(k) number is K183297.

When was Vis-U-All Low Temperature Sterilization Pouch/Tubing approved by the FDA?

Vis-U-All Low Temperature Sterilization Pouch/Tubing received FDA 510(k) clearance on 2019-01-03, under approval number K183297.

What company makes Vis-U-All Low Temperature Sterilization Pouch/Tubing?

Vis-U-All Low Temperature Sterilization Pouch/Tubing is manufactured by STERIS Corporation.

What is the FDA product code for Vis-U-All Low Temperature Sterilization Pouch/Tubing?

The FDA product code for Vis-U-All Low Temperature Sterilization Pouch/Tubing is FRG.

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Related Devices (Code: FRG)

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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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