FDA.reportPublic FDA data

Colpotomy tube

Definition
A sterile, hand-held, hollow cylindrical device designed to facilitate dissection of the cervical/vaginal junction during total laparoscopic-assisted hysterectomy. It is typically made of plastic material and functions as a transvaginal conduit for surgical instruments and as an anvil-like support during dissection. Its distal end is designed to fit tightly against the cervix, and its proximal end has a seal to prevent loss of peritoneum-distention gas [e.g., carbon dioxide (CO2)] used during the laparoscopic procedure. This is a single-use device.
GUDID devices
62
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00814247020611ClearView Total Uterine ManipulatorCLINICAL INNOVATIONS, LLCUM9502016-09-01
00888937015065RUMI II Koh-EfficientCoopersurgical, Inc.KC-RUMI-252022-11-10
00888937015072RUMI II Koh-EfficientCoopersurgical, Inc.KC-RUMI-302022-11-10
00888937015089RUMI II Koh-EfficientCoopersurgical, Inc.KC-RUMI-352022-11-10
00888937015096RUMI II Koh-EfficientCoopersurgical, Inc.KC-RUMI-402022-11-10
00888937015102RUMI II Koh-EfficientCoopersurgical, Inc.KCS-RUMI-252022-11-10
00888937015119RUMI II Koh-EfficientCoopersurgical, Inc.KCS-RUMI-302022-11-10
00888937015126RUMI II Koh-EfficientCoopersurgical, Inc.KCS-RUMI-352022-11-10
00888937015133RUMI II Koh-EfficientCoopersurgical, Inc.KCS-RUMI-402022-11-10
00888937015140Arch Koh-Efficient Coopersurgical, Inc.KC-ARCH-252022-11-10
00888937015157Arch Koh-Efficient Coopersurgical, Inc.KC-ARCH-302022-11-10
00888937015164Arch Koh-Efficient Coopersurgical, Inc.KC-ARCH-352022-11-10
00888937015171Arch Koh-Efficient Coopersurgical, Inc.KC-ARCH-402022-11-10
00888937015188Arch Koh-Efficient Coopersurgical, Inc.KCS-ARCH-252022-11-10
00888937015195Arch Koh-Efficient Coopersurgical, Inc.KCS-ARCH-302022-11-10
00888937015201Arch Koh-Efficient Coopersurgical, Inc.KCS-ARCH-352022-11-10
00888937015218Arch Koh-Efficient Coopersurgical, Inc.KCS-ARCH-402022-11-10
09349967000243ColpotomizOR TubeSURGI SUPPLIES INTERNATIONAL PTY. LTD.35mm2016-09-22
09349967000274ColpotomizOR TubeSURGI SUPPLIES INTERNATIONAL PTY. LTD.45mm2016-09-22
09349967000304ColpotomizOR Tube SystemSURGI SUPPLIES INTERNATIONAL PTY. LTD.35mm2016-09-22
09349967001424ColpotomizOR TubeTHE O R COMPANY PTY LTD35mm2017-11-16
09349967001455ColpotomizOR TubeTHE O R COMPANY PTY LTD45mm2017-11-16
09349967002513McCartney TubeTHE O R COMPANY PTY LTD35-TV2019-03-27
09349967002544McCartney TubeTHE O R COMPANY PTY LTD45-TV2019-03-27
09349967002575ColpotomizOR TubeTHE O R COMPANY PTY LTDC35-TV2019-03-27
09349967002605ColpotomizOR TubeTHE O R COMPANY PTY LTDC45-TV2019-03-27
09349967002698LiNA McCartney TubeTHE O R COMPANY PTY LTD35-TV2019-03-27
09349967002728LiNA McCartney TubeTHE O R COMPANY PTY LTD45-TV2019-03-27
09351599000119ColpoWave BalloonSURGITOOLS PTY. LTD.CBD2017-12-08
09351599000126ColpoWave BalloonSURGITOOLS PTY. LTD.CBD2017-12-08
09351599000317ColpoWave ColpotomizerSURGITOOLS PTY. LTD.CWD2017-12-08
09351599000324ColpoWave ColpotomizerSURGITOOLS PTY. LTD.CWD2017-12-08
09349967000267ColpotomizOR TubeSURGI SUPPLIES INTERNATIONAL PTY. LTD.35mm2016-09-22
09349967000298ColpotomizOR TubeSURGI SUPPLIES INTERNATIONAL PTY. LTD.45mm2016-09-22
09349967000328ColpotomizOR Tube SystemSURGI SUPPLIES INTERNATIONAL PTY. LTD.35mm2016-09-22
09349967001448ColpotomizOR TubeTHE O R COMPANY PTY LTD35mm2017-11-16
09349967001479ColpotomizOR TubeTHE O R COMPANY PTY LTD45mm2017-11-16
00888937015768THE RUMI SystemCoopersurgical, Inc. CPO-62022-11-10
20888937015069RUMI II Koh-EfficientCoopersurgical, Inc.KC-RUMI-252022-11-10
20888937015076RUMI II Koh-EfficientCoopersurgical, Inc.KC-RUMI-302022-11-10
20888937015083RUMI II Koh-EfficientCoopersurgical, Inc.KC-RUMI-352022-11-10
20888937015090RUMI II Koh-EfficientCoopersurgical, Inc.KC-RUMI-402022-11-10
20888937015106RUMI II Koh-EfficientCoopersurgical, Inc.KCS-RUMI-252022-11-10
20888937015113RUMI II Koh-EfficientCoopersurgical, Inc.KCS-RUMI-302022-11-10
20888937015120RUMI II Koh-EfficientCoopersurgical, Inc.KCS-RUMI-352022-11-10
20888937015137RUMI II Koh-EfficientCoopersurgical, Inc.KCS-RUMI-402022-11-10
20888937015144Arch Koh-Efficient Coopersurgical, Inc.KC-ARCH-252022-11-10
20888937015151Arch Koh-Efficient Coopersurgical, Inc.KC-ARCH-302022-11-10
20888937015168Arch Koh-Efficient Coopersurgical, Inc.KC-ARCH-352022-11-10
20888937015175Arch Koh-Efficient Coopersurgical, Inc.KC-ARCH-402022-11-10
20888937015182Arch Koh-Efficient Coopersurgical, Inc.KCS-ARCH-252022-11-10
20888937015199Arch Koh-Efficient Coopersurgical, Inc.KCS-ARCH-302022-11-10
20888937015205Arch Koh-Efficient Coopersurgical, Inc.KCS-ARCH-352022-11-10
20888937015212Arch Koh-Efficient Coopersurgical, Inc.KCS-ARCH-402022-11-10
09349967002537McCartney TubeTHE O R COMPANY PTY LTD35-TV2019-03-27
09349967002568McCartney TubeTHE O R COMPANY PTY LTD45-TV2019-03-27
09349967002599ColpotomizOR TubeTHE O R COMPANY PTY LTDC35-TV2019-03-27
09349967002629ColpotomizOR TubeTHE O R COMPANY PTY LTDC45-TV2019-03-27
09349967002711LiNA McCartney TubeTHE O R COMPANY PTY LTD35-TV2019-03-27
09349967002742LiNA McCartney TubeTHE O R COMPANY PTY LTD45-TV2019-03-27
00814247020499ClearView Total Uterine ManipulatorCLINICAL INNOVATIONS, LLCUM7502016-09-01
20814247020615ClearView Total Uterine ManipulatorCLINICAL INNOVATIONS, LLCUM9502016-09-01