FDA 510(k)

Syringe with permanently attached needle

N.º K: K213158 · 2022-07-21

SolicitanteBerpu Medical Technology Co., Ltd.

Fecha de decisión2022-07-21

Código de productoFMF

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Syringe with permanently attached needle is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K213158. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Syringe with permanently attached needle?

Syringe with permanently attached needle is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K213158.

When did Syringe with permanently attached needle receive FDA 510(k) clearance?

Syringe with permanently attached needle received FDA 510(k) clearance on 2022-07-21, under 510(k) number K213158.

Who is the listed applicant for Syringe with permanently attached needle?

The FDA 510(k) record lists Berpu Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Syringe with permanently attached needle?

The FDA product code for Syringe with permanently attached needle is FMF.

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Otros registros que enlistan a Berpu Medical Technology Co., Ltd. como solicitante

K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles K221045Insulin Syringes without needle K220061Safety Insulin Syringes K213811Sterile Hypodermic Syringes for Single Use K212514Safety Pen Needle for Single Use, Insulin Pen Needles K181447Safety insulin needle for single use

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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.