FDA 510(k)

Sterilization Pouch/Roll Made with Tyvek

Número K: K180672 · 2018-06-06

RequerenteSigma Medical Supplies Corporation

Data da decisão2018-06-06

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterilization Pouch/Roll Made with Tyvek is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Medical Supplies Corporation. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K180672. 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/Roll Made with Tyvek?

Sterilization Pouch/Roll Made with Tyvek is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Sigma Medical Supplies Corporation. The 510(k) number is K180672.

When did Sterilization Pouch/Roll Made with Tyvek receive FDA 510(k) clearance?

Sterilization Pouch/Roll Made with Tyvek received FDA 510(k) clearance on 2018-06-06, under 510(k) number K180672.

Who is the listed applicant for Sterilization Pouch/Roll Made with Tyvek?

The FDA 510(k) record lists Sigma Medical Supplies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Pouch/Roll Made with Tyvek?

The FDA product code for Sterilization Pouch/Roll Made with Tyvek 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

Outros registros que listam Sigma Medical Supplies Corporation como candidato(a)

K202462SIGMA Sterilization Pouch and Roll

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.