FDA 510(k)

Sterilization Pouch and Roll

Número K: K243179 · 2025-06-26

RequerenteYichang Xinxin Paper Products Co., Ltd.

Data da decisão2025-06-26

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.