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FDA 510(k)

Vis-U-All Low Temperature Sterilization Pouches

K-Number: K231500 · 2023-08-07

ApplicantSTERIS Corporation
Decision Date2023-08-07
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vis-U-All Low Temperature Sterilization Pouches is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-08-07 under 510(k) number K231500. 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?

Vis-U-All Low Temperature Sterilization Pouches is a medical device that received FDA 510(k) clearance on 2023-08-07. The listed applicant is STERIS Corporation. The 510(k) number is K231500.

When did Vis-U-All Low Temperature Sterilization Pouches receive FDA 510(k) clearance?

Vis-U-All Low Temperature Sterilization Pouches received FDA 510(k) clearance on 2023-08-07, under 510(k) number K231500.

Who is the listed applicant for Vis-U-All Low Temperature Sterilization Pouches?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vis-U-All Low Temperature Sterilization Pouches?

The FDA product code for Vis-U-All Low Temperature Sterilization Pouches is FRG.

Other records listing STERIS Corporation as applicant

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Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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