FDA 510(k)

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Número K: K233777 · 2024-05-24

Data da decisão2024-05-24

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K233777. 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 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K233777.

When did PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) receive FDA 510(k) clearance?

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) received FDA 510(k) clearance on 2024-05-24, under 510(k) number K233777.

Who is the listed applicant for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

The FDA 510(k) record lists Primed Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

The FDA product code for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) 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 Primed Medical Products, Inc. como candidato(a)

K262007PRIMED AAMI Level 3 Open Back Gowns K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)K252964PRIMED Surgical and Procedure Masks K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K240286PRIMED Surgical Masks and PRIMED Procedure Masks K213427PRIMED Pediatric Facemask

Ver todos os 8 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.