Coloplast

Coloplast — FDA 510(k) Submissions

Coloplast has submitted 15 FDA 510(k) premarket notifications since 2018, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Urethral, Catheter, Straight, Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse, Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit), Mesh, Surgical, For Stress Urinary Incontinence, Male . Use the specialty filter in the sidebar to narrow results.