3T/SEWOON Temperature Sensing Foley Catheters
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022287 FDA 510(k)
- FDA Product Code
- EZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 3T/SEWOON Temperature Sensing Foley Catheters are urological devices used for bladder drainage and irrigation. They incorporate a thermistor to provide continuous bladder temperature monitoring during catheterization.
These devices are used in clinical settings by healthcare professionals. They are supplied as single-use devices and are authorized under FDA 510(k) clearance K022287 with product code EZL and regulation number 876.5130.
Frequently asked questions
What clinical applications are these temperature sensing Foley catheters primarily used for?
These catheters are designed for bladder drainage and irrigation in clinical settings, with an added feature of continuous bladder temperature monitoring via an integrated thermistor. This makes them particularly useful in procedures where temperature stability is important, such as during urological interventions or when monitoring patient hydration status.
Are these catheters intended for single-use or reusable applications?
The 3T/SEWOON Temperature Sensing Foley Catheters are explicitly supplied as single-use devices. This ensures patient safety and hygiene, as they are not intended for reuse after a single clinical procedure.
What regulatory pathway was followed for FDA clearance of these catheters?
The device received FDA clearance through a 510(k) submission (K022287) under the Traditional clearance type, with a Substantially Equivalent determination. The product falls under product code EZL and regulation number 876.5130, categorized under Class II medical devices. The review was handled by the Gastroenterology and Urology (GU) Advisory Committee.
How should these catheters be stored before use?
While the device data does not specify storage conditions explicitly, single-use catheters like these are generally stored in a clean, dry environment protected from contamination. The manufacturer’s instructions (not provided here) should be followed for optimal shelf life and sterility preservation, as these catheters are intended for sterile use in clinical settings.
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: 3t/Sewoon Temperature Sensing Foley Catheters, 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS 510 (k)… - FDA.report, PDF TEMPERATURE-SENSING FOLEY CATHETERS - Medline, Temperature Sensing Foley Catheters - Medline, Standard 400 Series Temperature-Sensing Foley Catheters - BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022287 | Class II | Active |
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Manufacturer
- Manufacturer
- 3t Medical Systems, LLC
Sources (1)
- FDA 510(k) K022287 24 fields · synced Sep 19, 2026