FDA 510(k)

disposable 内視鏡手術器具、再利用可能な内視鏡手術器具

K番号: K171825 · 2018-02-13

申請者Hunan Handlike Minimally Invasive Surgery Co., Ltd.

決定日2018-02-13

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてHunan Handlike Minimally Invasive Surgery Co., Ltd.を記載するその他の記録

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