UC-Care Warming System
by Uc-Care Ltd
510(k) K090978
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090978 | Date10 Aug 2009 | StatusActive |
Official records
- FDA 510(k) database K090978
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEH
- FDA applicant
- UC-CARE , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
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.
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