510(k) Report

Devices descending from K935198

104 later devices reach Gastroenterology and Urology Guidewire Modifications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+11K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+11K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—
+12K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—