FDA 510(k)

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

Numéro K : K222440 · 2022-09-09

DemandeurSteris

Date de décision2022-09-09

Code produitFRG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2022-09-09 under 510(k) number K222440. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Steris. The 510(k) number is K222440.

When did Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays receive FDA 510(k) clearance?

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

Who is the listed applicant for Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays?

The FDA 510(k) record lists Steris 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/Tubing, PRO-LITE Sterilization Trays?

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

Essais cliniques associés

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Dispositifs connexes (Code : FRG)

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, LLC K253454HALYARD* 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.

Source officielle

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