FDA.report

Vaginal dilator

Definition
A firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.
GUDID devices
766
Last updated
2026-02-11 15:06:51

Related Product Codes

CodeDeviceSpecialtyClassDevices
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1590
HDXDilator, VaginalObstetrics/Gynecology2116
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery162
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology138
KXPStent, VaginalObstetrics/Gynecology213
GADRetractorGeneral, Plastic Surgery17
FFPDilator, RectalGastroenterology, Urology13

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
54026704791748PILLINGTELEFLEX INCORPORATEDIPN0176462022-12-08
54026704791786PILLINGTELEFLEX INCORPORATEDIPN0176502022-12-08
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14026704791696PILLINGTELEFLEX INCORPORATEDIPN0176412022-12-08
14026704791702PILLINGTELEFLEX INCORPORATEDIPN0176422022-12-08
14026704791757PILLINGTELEFLEX INCORPORATEDIPN0176472022-12-08
14026704791764PILLINGTELEFLEX INCORPORATEDIPN0176482022-12-08
00198506087981ELMED INCORPORATEDELMED INCORPORATED71415-012026-01-22
00198506087998ELMED INCORPORATEDELMED INCORPORATED71415-022026-01-22
00198506088001ELMED INCORPORATEDELMED INCORPORATED71415-032026-01-22
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04719961530506REBLOOM GRS VAGINAL TRAINERS Gshen medical CO., LTD.RGVT-380502025-04-25
04719961531008REBLOOM GRS VAGINAL TRAINERSGshen medical CO., LTD.RGVT-381002025-04-25
04719961531503REBLOOM GRS VAGINAL TRAINERSGshen medical CO., LTD.RGVT-381502025-04-25
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00840306836961Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.260-1662025-03-07
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