FDA 510(k) Applications Submitted by Troy Thome

FDA 510(k) Number	Submission Date	Device Name	Applicant
K180070	01/09/2018	SpeediCath Flex Coude Pro	Coloplast
K230165	01/20/2023	Luja CoudΘ (20118 Male CH8 - small packaging (Pocket size)), Luja CoudΘ (20111 Male CH10 - small packaging (Pocket size)), Luja CoudΘ (20112 Male CH12 - small packaging (Pocket size)), Luja CoudΘ (20114 Male CH14 - small packaging (Pocket size)), Luja Cou	Coloplast
K251116	04/11/2025	Luja CoudΘ	Coloplast Corp.
K241210	04/30/2024	Luja Coude	Coloplast Corp
K142309	08/19/2014	GEM Flow COUPLER Device and System	Synovis Life Technologies, Inc.
K132727	09/03/2013	GEM FLOW COUPLER DEVICE AND SYSTEM	SYNOVIS LIFE TECHNOLOGIES, INC.
K233101	09/26/2023	Luja Coude (20108 Male CH18 - large packaging)	Coloplast Corp