Device typeTransobturator needle, reusable: A hand-held manual surgical instrument with a sharp pyramidal or conical point intended to be used to create a percutaneous puncture using the transobturator approach (i.e., insertion points overlie the obturator space and the obturator foramen membrane is penetrated), for the surgical positioning of a sling used in the treatment of stress urinary incontinence (SUI), which may be associated with a prolapse. The distal working end is typically made of a stainless steel rod that is markedly curved or helicoidal (right- or left-angled), with a pointed tip and an eye or notch to help position the sling. The device can be made of metal and/or polymer materials. This is a reusable device.
FDA categoryInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device ID00890594000179
Catalog numberCAL-LHR2
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information