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Medical Monitor 27HS714S

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K243439

by LG Electronics Inc.

Identifiers

510(k) Number
K243439 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medical Monitor 27HS714S is a gastrointestinal endoscopy monitor (product code GCJ) designed for real-time visualization and imaging during endoscopic procedures. It provides high-resolution display of internal anatomical structures, enabling clinicians to assess and diagnose conditions within the gastrointestinal or urinary tracts with precision.

This device is supplied as a reusable medical monitor, intended for use in clinical settings such as hospitals, endoscopy suites, or urology departments. It is not sterile and requires proper cleaning and maintenance per manufacturer guidelines. The device holds FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for medical imaging equipment in endoscopy applications. Storage and handling must comply with facility protocols to ensure optimal performance and patient safety.

Frequently asked questions

What types of clinical procedures is this monitor specifically designed to support during real-time visualization?

This monitor is designed for real-time visualization during gastrointestinal and urinary tract endoscopic procedures. It provides high-resolution imaging to help clinicians assess internal anatomical structures, making it suitable for use in endoscopy suites, hospitals, or urology departments where such evaluations are performed.

Is this device intended for single-use or reusable applications, and what maintenance is required?

The Medical Monitor 27HS714S is a reusable device and is not sterile. After each use, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene, as it is intended for repeated use in clinical settings.

How is this device regulated, and what regulatory bodies have approved its use?

This device holds FDA 510(k) clearance and MDR authorization, meaning it has been evaluated and approved for compliance with regulatory standards for medical imaging equipment in endoscopy applications. The approvals confirm its substantial equivalence to existing devices and adherence to safety and performance requirements.

What storage and handling precautions should be taken to maintain the device’s performance?

The device must be stored and handled according to facility protocols to ensure optimal performance and patient safety. While specific storage conditions aren’t detailed, adherence to general medical equipment guidelines—such as protecting it from physical damage, extreme temperatures, and contamination—is recommended to maintain its functionality for real-time endoscopic imaging.

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

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
LG Electronics Inc.
FDA Applicant
Lg Electronics.Inc

Sources (2)

  • FDA 510(k) K243439 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026