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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 a medical device manufactured by Hunan Handlike Minimally Invasive Surgery Co., Ltd.. It received FDA 510(k) clearance on 2018-02-13 under approval 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. It is manufactured by Hunan Handlike Minimally Invasive Surgery Co., Ltd.. The 510(k) number is K171825.

When was Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument approved by the FDA?

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

What company makes Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument?

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument is manufactured by Hunan Handlike Minimally Invasive Surgery Co., Ltd..

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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Related PubMed Literature

PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018) PMID: 29602568 Evaluation of Ophthalmic Surgical Instrument Sterility Using Short-Cycle Sterilization for Sequential Same-Day Use. Ophthalmology (2018)

Other Devices by Hunan Handlike Minimally Invasive Surgery Co., Ltd.

K233036Ultrasonic Surgical System

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Official Source

View on FDA Database →

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