510(k) Report

Devices descending from K161672

10 later devices reach SpeediCath Flex Coude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180070SpeediCath Flex Coude ProColoplast20189—
+2K190620SpeediCath Flex Coude ProColoplast20198—
+3K230165Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10…Coloplast20234—
+3K222059SpeediCath Flex SetColoplast20220—
+3K200142SpeediCath SoftColoplast20201—
+4K262045Luja SoftColoplast A.S.20260—
+4K241210Luja CoudeColoplast Corp.20242—
+4K233101Luja Coude (20108 Male CH18 - large packaging)Coloplast Corp.20230—
+5K251116Luja CoudéColoplast Corp.20250—
+5K250270Luja SetColoplast Corp.20250—