510(k) Report

Devices descending from K211577

2 later devices reach SoftFix Balloon Trocar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252714C-Lant PortVigor Medical Technologies, Ltd.20260—
+1K233263Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd.20240—