510(k) Report

Devices descending from K172712

2 later devices reach gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242664gentleheel® Adult Incision DeviceGri-Alleset, Inc.20240—
+1K220917gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri-Alleset, Inc.20221—