510(k) K192468

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter by Hangzhou Bever Medical Devices Co., Ltd. — Product Code GBM

K192468 is an FDA 510(k) premarket notification submitted by Hangzhou Bever Medical Devices Co., Ltd. for the device "Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter". The FDA issued a decision of Substantially Equivalent on November 27, 2019. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hangzhou Bever Medical Devices Co., Ltd. has at least 3 other 510(k) clearances on record.