FDA 510(k)

Medicom Sterilization Pouch and Reel

N.º K: K243431 · 2025-02-21

SolicitanteMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.

Fecha de decisión2025-02-21

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medicom Sterilization Pouch and Reel is the device name listed in this FDA 510(k) record. The listed applicant is Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K243431. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medicom Sterilization Pouch and Reel?

Medicom Sterilization Pouch and Reel is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.. The 510(k) number is K243431.

When did Medicom Sterilization Pouch and Reel receive FDA 510(k) clearance?

Medicom Sterilization Pouch and Reel received FDA 510(k) clearance on 2025-02-21, under 510(k) number K243431.

Who is the listed applicant for Medicom Sterilization Pouch and Reel?

The FDA 510(k) record lists Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medicom Sterilization Pouch and Reel?

The FDA product code for Medicom Sterilization Pouch and Reel is FRG.

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Dispositivos relacionados (Código: 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.

Fuente oficial

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