510(k) Report

Devices descending from K170897

6 later devices reach Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.20232—
+1K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd20212—
+2K25409525G Huber NeedleMartech Medical Products20260—
+2K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20251—
+2K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus…Intera Oncology, Inc.20210—
+3K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20250—