UC-Care Warming System
FDA 510(k)Class II (US FDA 510(k))
by Uc-Care Ltd
Identifiers
- 510(k) Number
- K090978 FDA 510(k)
- FDA Product Code
- GEH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4350 FDA 510(k)
- Regulation Number
- 878.4350 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The UC-Care Warming System is a cryosurgical accessory designed to transfer heat to urethral tissue during prostatic cryosurgical procedures. It falls under the classification of a unit for cryosurgical accessories and is intended for use with cryosurgical systems cleared for prostate applications.
The system comprises a urethral catheter, tubing set, and a warming kit, which includes a fluid warmer and peristaltic pump. It is supplied as a single-use device and is regulated under FDA 510(k) clearance (K090978) with a classification under regulation 878.4350. No MRI safety or reusable specifications are noted in the data.
Frequently asked questions
What is the primary purpose of the UC-CARE Warming System during a prostate procedure?
The UC-CARE Warming System is designed to transfer heat to urethral tissue specifically during prostatic cryosurgical procedures. This helps prevent potential urethral injury or stenosis by maintaining tissue temperature, ensuring safer and more effective cryotherapy for the prostate.
Is the UC-CARE Warming System intended for reuse, or is it meant to be used only once?
The UC-CARE Warming System is explicitly supplied as a single-use device. This means it should not be reused after a single procedure to ensure patient safety and sterility.
What components are included in the UC-CARE Warming System kit?
The system includes a urethral catheter, a tubing set, and a warming kit that consists of a fluid warmer and a peristaltic pump. These components work together to deliver controlled warmth to the urethra during cryosurgical procedures.
How is the UC-CARE Warming System regulated in the U.S.?
The UC-CARE Warming System is regulated under FDA 510(k) clearance (K090978) and falls under the classification of a unit for cryosurgical accessories. It was determined to be substantially equivalent to a predicate device and is categorized under regulation 878.4350.
Are there any special handling or storage requirements for the UC-CARE Warming System?
Since the system is single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediate use to maintain sterility and functionality. No specific storage conditions (e.g., refrigeration) are mentioned in the data.
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: UC-CARE WARMING SYSTEM (K090978) — FDA 510 (k) | Innolitics, PDF 510(k) Number K R090?7 - Food and Drug Administration, UC-CARE WARMING SYSTEM 510 (k) K090978 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090978 | Class II | Active |
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Manufacturer
- Manufacturer
- Uc-Care Ltd
- FDA Applicant
- UC-CARE , Ltd.
Sources (1)
- FDA 510(k) K090978 24 fields · synced Sep 19, 2026