FDA 510(k) Applications for Medical Device Product Code: OTM ()

FDA 510(k) Applications for Medical Device Product Code "OTM"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K053371	AMERICAN MEDICAL SYSTEMS, INC.	AMS MALE TRANSOBTURATOR SLING SYSTEM	02/03/2006
K182169	Boston Scientific Corporation	AdVance XP Male Sling	11/27/2018
K211847	Boston Scientific Corporation	AdVance XP Male Sling System	12/20/2021
K063079	CL MEDICAL	I-STOP TRANS OBTURATOR MALE SLING	11/07/2006
K231891	Coloplast	Virtue Male Sling System with Alexis Wound Retractor Convenience Kit	09/25/2023
K111881	COLOPLAST A/S	VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT	08/17/2011
K101297	COLOPLAST A/S	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020	06/03/2010
K091152	COLOPLAST A/S	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020	05/07/2009
K113496	COLOPLAST A/S	VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT	02/14/2012
K082640	COLOPLAST MANUFACTURING US, LLC	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM	10/17/2008
K062341	SPECIALITIES REMEEX INTERNATIONAL, S.L.	MALE REMEEX SYSTEM	11/02/2006