FDA.reportPublic FDA data

Urethral dilator, single-use

Definition
A slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a single-use device.
GUDID devices
59
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850012846338PROSTAGRIP™LSI Solutions, Inc.0813582024-04-19
06936881102516Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0722102023-07-10
06936881102523Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0724102023-07-10
06936881102530Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0726102023-07-12
06936881136382Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0808102023-07-12
06936881136399Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0810102023-07-12
06936881136405Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0812102023-07-12
06936881136412Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0814102023-07-12
06936881136429Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0816102023-07-12
06936881136436Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0818102023-07-12
06936881136443Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0820102023-07-12
06936881136450Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0822102023-07-12
06936881136467Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0824102023-07-12
06936881136474Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0826102023-07-12
06936881136498Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0501102023-07-10
06944932769885Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0502102023-07-10
06976358503538SEPLOUSEPLOU (ZHUHAI) CO.,LTD.SPUD0122S2026-05-14
06976358503545SEPLOUSEPLOU (ZHUHAI) CO.,LTD.SPUD0124S2026-05-14
06976358503552SEPLOUSEPLOU (ZHUHAI) CO.,LTD.SPUD0126S2026-05-14
06976358503569SEPLOUSEPLOU (ZHUHAI) CO.,LTD.SPUD04242026-05-14
06976358503576SEPLOUSEPLOU (ZHUHAI) CO.,LTD.SPUD0420S2026-05-14
06976358503583SEPLOUSEPLOU (ZHUHAI) CO.,LTD.SPUD0426S2026-05-14
00853095008341Optilume Basic Urological Dilation catheterUrotronic, Inc.11472025-07-18
00853095008358Optilume Basic Urological Dilation catheterUrotronic, Inc.11472025-07-18
00853095008365Optilume Basic Urological Dilation catheterUrotronic, Inc.11472025-07-18
00853095008372Optilume Basic Urological Dilation catheterUrotronic, Inc.11472025-07-18
00853095008389Optilume Basic Urological Dilation catheterUrotronic, Inc.11472025-07-18
00853095008396Optilume Basic Urological Dilation catheterUrotronic, Inc.11472025-07-18
10850012846335PROSTAGRIP™LSI Solutions, Inc.0813582024-04-19
06936881136481Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0601102023-07-12
16936881102537Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0726102023-07-12
16936881136389Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0808102023-07-12
16936881136396Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0810102023-07-12
16936881136402Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0812102023-07-12
16936881136419Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0814102023-07-12
16936881136426Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0816102023-07-12
16936881136433Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0818102023-07-12
16936881136440Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0820102023-07-12
16936881136457Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0822102023-07-12
16936881136464Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0824102023-07-12
16936881136471Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0826102023-07-12
06936881140716Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0505102023-07-10
16936881102513Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0722102023-07-10
16936881102520Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0724102023-07-10
16936881136495Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0501102023-07-10
16944932769882Wellead Urethral DilatorWell Lead Medical Co.,LtdU02A0502102023-07-10
08718455508270MED pro Medical B.V.MED pro Medical B.V.MD6/162022-09-09
00810116021383Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 4mm x 4cm2020-02-25
00810116021390Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 4mm x 10cm2020-02-25
00810116021406Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 5mm x 4cm2020-02-25
00810116021413Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 5mm x 10cm2020-02-25
00810116021420Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 6mm x 4cm2020-02-25
00810116021437Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 6mm x 10cm2020-02-25
00810116021444Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 4mm x 4cm Kit2020-02-25
00810116021451Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 4mm x 10cm Ki2020-02-25
00810116021468Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 5mm x 4cm Kit2020-02-25
00810116021475Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 5mm x 10cm Ki2020-02-25
00810116021482Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 6mm x 4cm Kit2020-02-25
00810116021499Dornier MedTechDORNIER MEDTECH AMERICA, INC.Equinox Ureteral Dilatation Balloon, 6mm x 10cm Ki2020-02-25