FDA 510(k)

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument

N.º K: K171825 · 2018-02-13

SolicitanteHunan Handlike Minimally Invasive Surgery Co., Ltd.

Fecha de decisión2018-02-13

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Handlike Minimally Invasive Surgery Co., Ltd.. It received FDA 510(k) clearance on 2018-02-13 under 510(k) number K171825. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument?

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument is a medical device that received FDA 510(k) clearance on 2018-02-13. The listed applicant is Hunan Handlike Minimally Invasive Surgery Co., Ltd.. The 510(k) number is K171825.

When did Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument receive FDA 510(k) clearance?

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument received FDA 510(k) clearance on 2018-02-13, under 510(k) number K171825.

Who is the listed applicant for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument?

The FDA 510(k) record lists Hunan Handlike Minimally Invasive Surgery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument?

The FDA product code for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument is GEI.

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Fuente oficial

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