FDA.reportPublic FDA data

Transobturator needle, reusable

Definition
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.
GUDID devices
12
Last updated
2022-08-11 09:17:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00857492008003Transobturator Helical, Left IntroducerCaldera Medical, Inc.CAL-HL322022-08-03
00857492008010Transobturator Helical, Right IntroducerCaldera Medical, Inc.CAL-HR322022-08-03
00890594000933Transobturator Inside-Out, Right 3.2 mm IntroducerCaldera Medical, Inc.CAL-IOR322019-11-05
00890594000940Transobturator Inside-Out, Left 3.2 mm IntroducerCaldera Medical, Inc.CAL-IOL322019-11-05
00890594000018Transobturator Helical, Left IntroducerCaldera Medical, Inc.CAL-HL042019-09-30
00890594000148Transobturator Helical, Right IntroducerCaldera Medical, Inc.CAL-HR052019-09-30
00890594000162Transobturator Large Helical, Left IntroducerCaldera Medical, Inc.CAL-LHL12019-09-30
00890594000179Transobturator Large Helical, Right IntroducerCaldera Medical, Inc.CAL-LHR22019-09-30
00890594000186Transobturator Inside-Out, Left IntroducerCaldera Medical, Inc.CAL-IO62019-09-30
00890594000209Transobturator Inside-Out, Right IntroducerCaldera Medical, Inc.CAL-IO72019-09-30
00890594000216Transobturator Hook IntroducerCaldera Medical, Inc.CAL-TB032019-09-30
00890594000278Winged Guide AccessoryCaldera Medical, Inc.CAL-WI2019-09-30