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Monopolar Single Use Laparoscopic Instrument

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171523

by GETSCH+HILLER Medizintechnik GmbH

Identifiers

510(k) Number
K171523 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)

The Monopolar Single Use Laparoscopic Instrument is a single-use, monopolar electrosurgical device designed for laparoscopic procedures. It facilitates tissue dissection, coagulation, and cutting within minimally invasive surgeries, utilising high-frequency electrical current to achieve precise control and haemostasis.

This instrument is supplied sterile and intended for single-use only, ensuring compliance with surgical best practices. Available in two configurations—either as a two-part system or a four-part system—it is regulated under FDA 510(k) clearance (K171523) and classified under product code GEI. It is not MRI-safe and must be stored in accordance with manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

What types of laparoscopic procedures is this instrument designed for, and how does it work during surgery?

This instrument is designed for laparoscopic procedures where precise tissue dissection, coagulation, and cutting are required. It uses a monopolar electrosurgical approach, delivering high-frequency electrical current to achieve controlled tissue effects, such as haemostasis (stopping bleeding) and cutting. It’s ideal for minimally invasive surgeries where traditional open surgery tools aren’t feasible.

Is this instrument reusable, or is it strictly for single-use? How does that affect its sterility?

This instrument is strictly single-use only, as explicitly stated in its design. This ensures sterility is maintained throughout its intended use, eliminating the risk of cross-contamination between patients. The sterile packaging is designed to preserve functionality and safety for one procedure only, aligning with surgical best practices.

What configurations does this instrument come in, and how might that impact my choice for a procedure?

The instrument is available in two configurations: a two-part system or a four-part system. The choice depends on procedural needs—some surgeries may require the modularity of the four-part system for added flexibility, while others may find the two-part system sufficient. The manufacturer’s guidelines should be consulted to match the system to the specific surgical approach.

Can this device be used in an MRI environment, or are there any special storage requirements?

This device is not MRI-safe, meaning it should never be used in an MRI environment due to potential interference or safety risks. Storage must follow the manufacturer’s instructions to preserve sterility and functionality, typically involving sealed packaging and protection from environmental contaminants until use.

How do I confirm the regulatory status of this device before purchasing or using it?

This device holds FDA 510(k) clearance (K171523) under product code GEI, indicating it’s been deemed substantially equivalent to a legally marketed predicate device. For full regulatory details, including compliance and classification, refer to the FDA’s device database or contact the manufacturer, GETSCH+HILLER Medizintechnik GmbH, for official documentation.

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. Sources consulted: Home - GETSCH+HILLER MEDIZINTECHNIK, PDF K171523 - Monopolar Single Use Laparoscopic Instrument, PDF August 22, 2017 Getsch + Hiller Medizintechnik GmbH Werner Hiller CEO ..., Monopolar Single Use Laparoscopic Instrument (K171523) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
GETSCH+HILLER Medizintechnik GmbH

Sources (1)

  • FDA 510(k) K171523 24 fields · synced Oct 6, 2026