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FDA 510(k)

Vis-U-All Low Temperature Sterilization Pouch/Tubing

K-Number: K160908 · 2016-07-22

ApplicantSTERIS Corporation
Decision Date2016-07-22
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vis-U-All Low Temperature Sterilization Pouch/Tubing is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K160908. 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 2016-07-22. The listed applicant is STERIS Corporation. The 510(k) number is K160908.

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

Vis-U-All Low Temperature Sterilization Pouch/Tubing received FDA 510(k) clearance on 2016-07-22, under 510(k) number K160908.

Who is the listed applicant for Vis-U-All Low Temperature Sterilization Pouch/Tubing?

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 Pouch/Tubing?

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