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FDA 510(k)

Self-Seal Sterilization Pouch and Roll

N.º K: K251177 · 2025-12-12

SolicitanteGuangdong Maidi Medical Co., Ltd.
Fecha de decisión2025-12-12
Código de productoFRG
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Self-Seal Sterilization Pouch and Roll is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Maidi Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K251177. 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 Self-Seal Sterilization Pouch and Roll?

Self-Seal Sterilization Pouch and Roll is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Guangdong Maidi Medical Co., Ltd.. The 510(k) number is K251177.

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

Self-Seal Sterilization Pouch and Roll received FDA 510(k) clearance on 2025-12-12, under 510(k) number K251177.

Who is the listed applicant for Self-Seal Sterilization Pouch and Roll?

The FDA 510(k) record lists Guangdong Maidi Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Self-Seal 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.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.

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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