Identifiers
- 510(k) Number
- K232435 FDA 510(k)
- FDA Product Code
- EOB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4760 FDA 510(k)
- Regulation Number
- 874.4760 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rhinolaryngoscope system is a medical device used for examination of the nasal passages and larynx. It consists of single-use rhinolaryngoscopes and an image processor (model: VLM-02). This system is designed for diagnostic procedures in the ear, nose, and throat area.
The device is supplied as a single-use system and is not intended for reuse. It is regulated under FDA 510(k) clearance with product code EOB and is classified as Class II medical device. The system includes multiple models of rhinolaryngoscopes and is authorized for use in medical settings for diagnostic procedures.
Frequently asked questions
What is the Rhinolaryngoscope system used for?
The Rhinolaryngoscope system is designed for diagnostic examination of the nasal passages and larynx in medical settings. It is specifically intended for procedures in the ear, nose, and throat area to help clinicians visualize and diagnose various conditions.
Is the Rhinolaryngoscope system reusable or single-use?
The Rhinolaryngoscope system is supplied as a single-use device and is not intended for reuse. This design helps prevent cross-contamination between patients and ensures optimal performance for each diagnostic procedure.
What components are included in the Rhinolaryngoscope system?
The system consists of single-use rhinolaryngoscopes and an image processor with model number VLM-02. Multiple models of rhinolaryngoscopes are available to accommodate different clinical needs and examination requirements.
What is the regulatory status of this device?
The Rhinolaryngoscope system is regulated under FDA 510(k) clearance with product code EOB and is classified as a Class II medical device. It received FDA clearance on April 26, 2024, with decision code SESE, indicating it is substantially equivalent to predicate devices.
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: HugeMed, HugeMed, PDF April 26, 2024 Shenzhen HugeMed Medical Technical Development Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232435 | Class II | Active |
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Manufacturer
Sources (1)
- FDA 510(k) K232435 24 fields · synced Sep 22, 2026