FDA 510(k)

SteriTite Containers System & MediTray Products

N.º K: K161415 · 2017-02-10

Fecha de decisión2017-02-10

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

SteriTite Containers System & MediTray Products is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K161415. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SteriTite Containers System & MediTray Products?

SteriTite Containers System & MediTray Products is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Case Medical, Inc.. The 510(k) number is K161415.

When did SteriTite Containers System & MediTray Products receive FDA 510(k) clearance?

SteriTite Containers System & MediTray Products received FDA 510(k) clearance on 2017-02-10, under 510(k) number K161415.

Who is the listed applicant for SteriTite Containers System & MediTray Products?

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

What is the FDA product code for SteriTite Containers System & MediTray Products?

The FDA product code for SteriTite Containers System & MediTray Products is FRG.

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Otros registros que enlistan a Case Medical, Inc. como solicitante

K252854SteriTite Container System with MediTray Products K221492SteriTite Container System with MediTray Parts K212711SteriTite Container System with MediTray Products K173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.