FDA.reportPublic FDA data

Rigid optical hysteroscope

Definition
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is typically used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.
GUDID devices
30
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10884521750203TruClearCovidien LP722050512018-12-21
20884521724706TruClearCovidien LP72055612023-09-25
00848657077439AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.5729BL-H2025-08-25
00848657077514AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HS85002025-08-25
00848657077521AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HS57002025-08-25
00848657077569AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.5729FL2025-08-25
04059453061522Hermann Medizintechnik GmbHHermann Medizintechnik GmbHH51-021-0012025-08-25
04059453061850Hermann Medizintechnik GmbHHermann Medizintechnik GmbHH51-210-0012025-08-25
04059453061898Hermann Medizintechnik GmbHHermann Medizintechnik GmbHH51-220-0012025-08-25
04048551367537NAKarl Storz GmbH & Co. KG26208AMA2025-03-27
00190776389826MillenniumAvalign Technologies, Inc.72-51400302024-11-18
00190776389994MillenniumAvalign Technologies, Inc.72-31400312024-11-18
00810143892765Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-9029-302AA2024-10-09
00810143892772Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-9029-302BA2024-10-09
00810143892789Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-9040-302ASA2024-10-09
00810143892796Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-9040-302AA2024-10-09
00810143892802Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-9040-302ESA2024-10-09
00810143892819Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-9040-302BSA2024-10-09
00810143892826Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-9040-302BA2024-10-09
00810143892833Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.STS-9040-302CA2024-10-09
25420045510347Omni Hysteroscopy Light SetHologic, Inc.60-250-22024-09-26
25420045510354Omni Hysteroscopy Standard SetHologic, Inc.60-250-12024-09-26
G5921002030HD0StahlS.H. Medical Corporation10020.30HD 2024-02-23
G5921002930HD0StahlS.H. Medical Corporation10029.30HD2024-02-23
00842180186576ELMEDELMED INCORPORATED31-A3166.72024-02-20
00190776301132MillenniumAvalign Technologies, Inc.72-31400122023-11-15
00190776301620MillenniumAvalign Technologies, Inc.72-51270302023-11-15
04035873071419HYST 2,9/30/300 AK HD COVIDIENHenke-Sass, Wolf GmbH83000579452022-12-16
04035873071426HYST/USH/1DBH/Ø2,9/302/30/TL/WE/COVIDIENHenke-Sass, Wolf GmbH83000579462022-12-16
04035873071433HYST/DSSH/Ø5,5/AK/5CH/30°/2FH/OL/WE/COVIHenke-Sass, Wolf GmbH83000579472022-12-16