FDA 510(k)

Self-Seal Sterilization Pouch and Roll

Numéro K : K251177 · 2025-12-12

DemandeurGuangdong Maidi Medical Co., Ltd.

Date de décision2025-12-12

Code produitFRG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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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.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.

Source officielle

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