510(k) Report

Devices descending from K201884

2 later devices reach ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252535Inno-Switch™ Laparoscopic InstrumentsTaiwan Surgical Corporation20260—
+1K234147ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm…Microline Surgical, Inc.20240—