510(k) Report

Devices descending from K952895

4 later devices reach CMS Urethral Warmer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963970Endocare Cryocare Cryosurgical System Urethral Warming SystemEndocare, Inc.19972—
+1K955011Candela HCS 2000 Uretheral Warmer CatheterCandela Laser Corp.19960—
+2K211149Urethral Warming Catheter KitVarian Medical Systems, Inc.20220—
+2K090978UC-Care Warming SystemUC-CARE, Ltd.20090—