510(k) Report

Devices descending from K231401

1 later device reach Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…Poly Medicure Limited20260—