Kiltex Probe Cover
FDA 510(k)Class II (US FDA 510(k))
by Kiltex Corp.
Identifiers
- 510(k) Number
- K961029 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 Kiltex Probe Cover is a protective sheath designed for ultrasound imaging probes, classified under the product code IYO as a system component for pulsed-echo ultrasonic imaging. It serves as a barrier to maintain sterility and hygiene while ensuring uninterrupted acoustic transmission during diagnostic procedures.
This device is intended for single-use applications in radiology settings and is supplied sterile. It is compatible with MRI environments and is available in sizes tailored to standard ultrasound probe diameters. Authorized under FDA 510(k) clearance (K961029), it adheres to Class II special controls for imaging devices and must be stored according to manufacturer instructions to preserve sterility.
Frequently asked questions
What is the Kiltex Probe Cover used for in clinical settings?
The Kiltex Probe Cover is designed as a protective sheath specifically for ultrasound imaging probes. Its primary purpose is to act as a sterile barrier during diagnostic procedures, ensuring hygiene while maintaining clear acoustic transmission for imaging. This makes it ideal for radiology settings where maintaining sterility is critical.
Is the Kiltex Probe Cover meant for reuse, or is it intended for single-use only?
The Kiltex Probe Cover is explicitly intended for single-use applications. This design choice aligns with best practices for maintaining sterility and hygiene in medical imaging, particularly in radiology, where contamination risks must be minimized.
How do I know if the Kiltex Probe Cover is compatible with my ultrasound probe?
The Kiltex Probe Cover is available in sizes tailored to standard ultrasound probe diameters, so compatibility depends on whether your probe falls within those standard dimensions. Since exact probe measurements aren’t specified, you should verify the probe’s diameter against the manufacturer’s sizing guide for the Probe Cover to ensure a proper fit.
Can the Kiltex Probe Cover be used in an MRI environment, and why?
Yes, the Kiltex Probe Cover is explicitly stated as compatible with MRI environments. This means it can be safely used during MRI procedures without interfering with the imaging process or posing risks to the patient or equipment, as it is designed to maintain functionality while providing a sterile barrier.
How should I store the Kiltex Probe Cover to ensure it remains sterile?
The Kiltex Probe Cover is supplied sterile, so storage must follow the manufacturer’s instructions to preserve that sterility. While specific storage details aren’t provided, typical single-use sterile barriers require protection from contamination—such as keeping them in sealed packaging until use—and avoiding exposure to moisture, dust, or direct handling with unsterile surfaces.
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: K961029 FDA 510 (k) - KILTEX PROBE COVER | Kiltex Corp., KILTEX PROBE COVER (K961029) — FDA 510 (k) | Innolitics, Kiltex Probe Cover 510 (k) FDA Premarket Notification K961029 KILTEX CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961029 | Class II | Active |
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Manufacturer
- Manufacturer
- Kiltex Corp.
Sources (1)
- FDA 510(k) K961029 24 fields · synced Sep 19, 2026