Sheathes Sterile Ultrasound Gel
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130041 FDA 510(k)
- FDA Product Code
- MUI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Sheathes Sterile Ultrasound Gel is a coupling medium designed to facilitate the transmission of sound waves between an ultrasound transducer and a patient. It functions as a conductive interface to ensure clear imaging during diagnostic ultrasound procedures.
This product is supplied as a sterile ultrasound gel and is regulated under FDA 510(k) clearance. It is intended for use in clinical settings as a coupling agent for ultrasound equipment.
Frequently asked questions
What is the primary purpose of Sheathes Sterile Ultrasound Gel?
This product is designed to act as a conductive interface or coupling medium. It facilitates the transmission of sound waves between an ultrasound transducer and the patient's skin to ensure clear imaging during diagnostic procedures.
Is this ultrasound gel sterile?
Yes, the product is supplied as a sterile ultrasound gel. Sterility is required to maintain clinical safety standards when using the gel as a coupling agent during diagnostic ultrasound examinations.
What is the regulatory status of this device?
Sheathes Sterile Ultrasound Gel is regulated under FDA 510(k) clearance, identified by k-number K130041. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices in the radiology specialty.
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: Ultrasound Probe Covers | Sheathes, 60001 Ultrasound Gel - Sheathes, SheathesGel Ultrasound Gel - Medline, Sheathing Technologies Ultrasound Probe Cover Sheathes - Ultrasound ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130041 | Class II | Active |
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Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
Sources (1)
- FDA 510(k) K130041 24 fields · synced Sep 23, 2026