# UC-Care Warming System > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Uc-Care Ltd](https://devicerts.com/manufacturers/uc-care-ltd) (FDA registration: Israel) - Name in the registry: UC-CARE WARMING SYSTEM - Device class: Class II (US FDA) - FDA product code: GEH ## Overview *AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.* 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. ## Registrations and authorizations - **510(k)** · FDA 510(k) · United States · K090978 · decision 2009-08-10 · decision SESE · status: Active ## Recalls No recall on record. ## Identifiers - 510(k) Number: K090978 [FDA 510(k)] - FDA product code: GEH [FDA 510(k)] ## Classification - Device class: Class II [FDA 510(k)] - Regulation: 21 CFR Part 878.4350 [FDA 510(k)] - Advisory committee: General, Plastic Surgery [FDA 510(k)] - FDA decision: SESE [FDA 510(k)] ## Source and citation - Cite as: UC-Care Warming System, Uc-Care Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/uc-care-warming-system-geh (data as of 2026-11-14). - Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/) - Registry records last synced: 2026-10-22 - Statuses computed as of: 2026-11-14 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/uc-care-warming-system-geh - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.