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FDA 510(k)

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument

K-Number: K171825 · 2018-02-13

ApplicantHunan Handlike Minimally Invasive Surgery Co., Ltd.
Decision Date2018-02-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Hunan Handlike Minimally Invasive Surgery Co., Ltd. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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