Identifiers
- 510(k) Number
- K812686 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sinuscope is an ultrasound system designed for medical visualization. It functions as a diagnostic tool used to assist in the examination of the sinus cavities.
This device is manufactured by Jedmed Instrument Co. and has received FDA 510(k) clearance. It is intended for use in clinical settings as part of ENT examination and diagnostic procedures.
Frequently asked questions
What is the primary clinical use of the Sinuscope?
The Sinuscope is an ultrasound system specifically designed to assist clinicians in the visualization and diagnostic examination of the sinus cavities during ENT procedures.
Who is the manufacturer of this diagnostic device?
This device is manufactured by Jedmed Instrument Co., located in Walker, Michigan.
What is the regulatory status of the Sinuscope?
The Sinuscope has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to other legally marketed 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: JEDMED | ENT Instruments, Exam Chairs & Medical Equipment Manufacturer, ENT Equipment - JEDMED, Jedmed Instrument Sinuscope - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K812686 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jedmed Instrument Co.
Sources (1)
- FDA 510(k) K812686 24 fields · synced Sep 23, 2026