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Pediatric Vaginal Stents and Dilators

Project Lead: Baylor College of Medicine
Year: 

2016

Anticipated Classification:

Class II

Anticipated Regulatory Path:

510(k)

Initial Development Stage:

Prototyping

Current Development Stage:

Prototyping

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.

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The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) serves as a critical device development resource by providing expert advice, support services, and fund management of pediatric device innovation.

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