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FDA 510(k)

Sterilization Pouch and Roll

N.º K: K243179 · 2025-06-26

SolicitanteYichang Xinxin Paper Products Co., Ltd.
Fecha de decisión2025-06-26
Código de productoFRG
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterilization Pouch and Roll is the device name listed in this FDA 510(k) record. The listed applicant is Yichang Xinxin Paper Products Co., Ltd.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243179. 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 Sterilization Pouch and Roll?

Sterilization Pouch and Roll is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Yichang Xinxin Paper Products Co., Ltd.. The 510(k) number is K243179.

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

Sterilization Pouch and Roll received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243179.

Who is the listed applicant for Sterilization Pouch and Roll?

The FDA 510(k) record lists Yichang Xinxin Paper Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Pouch and Roll?

The FDA product code for Sterilization Pouch and Roll is FRG.

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Dispositivos relacionados (Código: FRG)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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