Identifiers
- 510(k) Number
- K153004 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Clear Guide SCENERGY is a medical device designed for use in ultrasound-guided procedures. It is intended to assist healthcare professionals in performing invasive procedures with improved speed and accuracy.
The device is supplied by Clear Guide Medical and has received FDA 510(k) clearance with the product code JAK. It is designed for use in various medical specialties that utilize ultrasound for invasive procedures, including emergency medicine.
Frequently asked questions
What is the Clear Guide SCENERGY used for?
The Clear Guide SCENERGY is a medical device designed to assist healthcare professionals in performing ultrasound-guided invasive procedures with improved speed and accuracy. It is intended for use in various medical specialties that utilize ultrasound for invasive procedures, including emergency medicine.
How is the Clear Guide SCENERGY supplied?
The Clear Guide SCENERGY is supplied by Clear Guide Medical. The device is designed for single-use in clinical settings where ultrasound guidance is required for invasive procedures.
What regulatory approvals does the Clear Guide SCENERGY have?
The Clear Guide SCENERGY has received FDA 510(k) clearance with the product code JAK. It was determined to be substantially equivalent to predicate devices and reviewed by the Radiology Advisory Committee.
In which medical specialties can the Clear Guide SCENERGY be used?
The Clear Guide SCENERGY is designed for use in various medical specialties that utilize ultrasound for invasive procedures, with particular relevance to emergency medicine and other fields requiring precise ultrasound guidance.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153004 | Class II | Active |
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Manufacturer
- Manufacturer
- Clear Guide Medical
Sources (1)
- FDA 510(k) K153004 24 fields · synced Sep 21, 2026