FDA 510(k)

Safe Secure Sterilization Pouches and Rolls

Numéro K : K242839 · 2024-10-16

DemandeurShenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

Date de décision2024-10-16

Code produitFRG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Safe Secure Sterilization Pouches and Rolls is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K242839. 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 Safe Secure Sterilization Pouches and Rolls?

Safe Secure Sterilization Pouches and Rolls is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. The 510(k) number is K242839.

When did Safe Secure Sterilization Pouches and Rolls receive FDA 510(k) clearance?

Safe Secure Sterilization Pouches and Rolls received FDA 510(k) clearance on 2024-10-16, under 510(k) number K242839.

Who is the listed applicant for Safe Secure Sterilization Pouches and Rolls?

The FDA 510(k) record lists Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safe Secure Sterilization Pouches and Rolls?

The FDA product code for Safe Secure Sterilization Pouches and Rolls is FRG.

Essais cliniques associés

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Autres dossiers indiquant Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. en tant que demandeur

K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)K213358Surgical Mask

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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