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Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrum…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171825

by Hunan Handlike Minimally Invasive Surgery Co., Ltd.

Identifiers

510(k) Number
K171825 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device comprises both disposable and reusable endoscopic surgical instruments designed for minimally invasive procedures. The instruments are classified under the product code GEI (General, Plastic Surgery) and are intended for use in endoscopic surgeries, facilitating precise manipulation and dissection within confined anatomical spaces.

The disposable instruments are intended for single-use, while the reusable instruments require sterilisation between procedures. Both variants are authorised under FDA 510K clearance and the Medical Device Directive (MDD), ensuring compliance with regulatory standards. They are supplied sterile and must be stored according to manufacturer guidelines to maintain integrity and functionality.

Frequently asked questions

Are these instruments designed for use in specific types of surgeries, or are they general-purpose for endoscopic procedures?

These instruments are classified under product code GEI (General, Plastic Surgery) and are intended for minimally invasive endoscopic surgeries, particularly where precise manipulation and dissection in confined spaces are required. While they are versatile for endoscopic procedures, their primary classification aligns with general and plastic surgery applications, making them suitable for a broad range of minimally invasive techniques rather than a single specialty.

How should I store these instruments to ensure they remain sterile and functional?

Both the disposable and reusable variants are supplied sterile, but storage must follow the manufacturer’s guidelines to preserve sterility and integrity. The reusable instruments require sterilization between uses, while the disposables are intended for single-use only. Proper storage conditions—such as sealed packaging, controlled humidity, and protection from physical damage—are critical to maintaining their performance and sterility until use.

Can I reuse the disposable instruments, or are they strictly for one-time use?

The disposable instruments are explicitly designed for single-use only and should not be reused. Reusing them could compromise sterility, functionality, and patient safety. The reusable variant, on the other hand, is engineered for multiple uses with proper sterilization between procedures, as outlined in the manufacturer’s instructions.

What regulatory pathways have these instruments undergone, and how does that affect their use?

These instruments have been authorized through FDA 510(k) clearance and compliance with the Medical Device Directive (MDD), confirming they meet regulatory standards for safety and effectiveness. The FDA 510(k) clearance indicates they are deemed substantially equivalent to a legally marketed predicate device, while the MDD ensures adherence to European regulatory requirements. This dual authorization allows for use in both U.S. and EU markets, provided local regulations are followed.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hunan Handlike Minimally Invasive Surgery Co., Ltd.

Sources (2)

  • FDA 510(k) K171825 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026