Currently, there are no vaginal stents for either adult women or children that exist on the market, and vaginal dilators are only sized for adults with normal caliber vaginal cavities. The 3D printed Pediatric Vaginal Stents and Dilators will have improved functionality, fit, and performance specific to pediatric populations or women with significant vaginal stenosis. NCC-PDI has provided $50,000 in direct funding and initial regulatory consultation services.
Year:
2016
Anticipated Classification:
Class II
Anticipated Regulatory Path:
510(k)
Initial Development Stage:
Prototyping
Current Development Stage:
Prototyping
