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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K121805	AMERICAN MEDICAL SYSTEMS	AMS LARGE PORE POLYPROPHLENE MESH	10/16/2012
K051485	AMERICAN MEDICAL SYSTEMS, INC.	AMS PELVIC FLOOR REPAIR SYSTEM	08/03/2005
K010931	AMERICAN MEDICAL SYSTEMS, INC.	AMS SACRAL COLPOPEXY SLING, MODEL 72403501	04/09/2001
K122794	BOSTON SCIENTIFIC CORP.	UPSYLON Y MESH	12/18/2012
K171271	Boston Scientific Corporation	Polyform Synthetic Mesh	12/15/2017
K101722	C.R. BARD, INC.	ALYTE Y-MESH GRAFT	04/01/2011
K090739	C.R. BARD, INC.	BARD SACROCOLPOPEXY GRAFT	11/10/2009
K123337	CALDERA MEDICAL	VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM	02/21/2013
K120327	CALDERA MEDICAL, INC.	VERTESSA	05/10/2012
K150016	CALDERA MEDICAL, INC.	Vertessa Lite	04/06/2015
K123028	CALDERA MEDICAL, INC.	VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH	04/25/2013
K150023	CALDERA MEDICAL, INC.	Vertessa Lite Y-Mesh	04/06/2015
K112322	COLOPLAST A/S	RESTORELLE POLYPROPYLENE Y MESH	05/17/2012
K123914	COLOPLAST A/S	RESTORELLE Y CONTOUR	03/05/2013
K140116	COLOPLAST A/S	RESTORELLE Y CONTOUR MESH	02/12/2014
K122968	COLOPLAST CORP.	NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015	12/18/2012
K122440	COLOPLAST CORP.	RESTORELLE L	11/19/2012
K132061	COLOPLAST CORP.	RESTORELLE M, RESTORELLE XL	08/02/2013
K113205	ETHICON, INC.	ARTISYN Y-SHAPED MESH	06/11/2012
K013718	GYNECARE, A DIV. OF ETHICON, INC.	GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR	01/08/2002
K041632	MPATHY MEDICAL DEVICES, LTD.	MINIMESH POLYPROPYLENE MESH	11/17/2004
K053361	MPATHY MEDICAL DEVICES, LTD.	MODIFICATION TO: MINIMESH POLYPROPYLENE MESH	02/06/2006
K051245	PROXY BIOMEDICAL LTD.	POLYFORM SYNTHETIC MESH	06/17/2005