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OTO — Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed Class II

FDA Device Classification

Classification Details

Product Code
OTO
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
OB
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K171271boston scientific corporationPolyform Synthetic MeshDecember 15, 2017
K150016caldera medicalVertessa LiteApril 6, 2015
K150023caldera medicalVertessa Lite Y-MeshApril 6, 2015
K140116coloplastRESTORELLE Y CONTOUR MESHFebruary 12, 2014
K132061coloplastRESTORELLE M, RESTORELLE XLAugust 2, 2013
K123028caldera medicalVERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHApril 25, 2013
K123914coloplastRESTORELLE Y CONTOURMarch 5, 2013
K123337caldera medicalVERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMFebruary 21, 2013
K122794boston scientificUPSYLON Y MESHDecember 18, 2012
K122968coloplastNOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015December 18, 2012
K122440coloplastRESTORELLE LNovember 19, 2012
K121805american medical systemsAMS LARGE PORE POLYPROPHLENE MESHOctober 16, 2012
K113205ethiconARTISYN Y-SHAPED MESHJune 11, 2012
K112322coloplastRESTORELLE POLYPROPYLENE Y MESHMay 17, 2012
K120327caldera medicalVERTESSAMay 10, 2012
K101722c.r. bardALYTE Y-MESH GRAFTApril 1, 2011
K090739c.r. bardBARD SACROCOLPOPEXY GRAFTNovember 10, 2009
K053361mpathy medical devicesMODIFICATION TO: MINIMESH POLYPROPYLENE MESHFebruary 6, 2006
K051485american medical systemsAMS PELVIC FLOOR REPAIR SYSTEMAugust 3, 2005
K051245proxy biomedicalPOLYFORM SYNTHETIC MESHJune 17, 2005