FDA 510(k)

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Número K: K160908 · 2016-07-22

Data da decisão2016-07-22

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vis-U-All Low Temperature Sterilization Pouch/Tubing is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K160908. 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 Vis-U-All Low Temperature Sterilization Pouch/Tubing?

Vis-U-All Low Temperature Sterilization Pouch/Tubing is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is STERIS Corporation. The 510(k) number is K160908.

When did Vis-U-All Low Temperature Sterilization Pouch/Tubing receive FDA 510(k) clearance?

Vis-U-All Low Temperature Sterilization Pouch/Tubing received FDA 510(k) clearance on 2016-07-22, under 510(k) number K160908.

Who is the listed applicant for Vis-U-All Low Temperature Sterilization Pouch/Tubing?

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

What is the FDA product code for Vis-U-All Low Temperature Sterilization Pouch/Tubing?

The FDA product code for Vis-U-All Low Temperature Sterilization Pouch/Tubing 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 STERIS Corporation como candidato(a)

K261055AMSCO 700 Steam Sterilizer K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 K260766Celerity 5 HP Biological Indicator (LCB052)K252680Celerity™ 20 HP Biological Indicator K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 K243876VERIFY STEAM Integrating Indicator

Ver todos os 120 dispositivos →

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.