FDA.reportPublic FDA data

Endoscopic overtube, single-use

Definition
"A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be ""shape locked"" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device."
GUDID devices
17
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00724995183615GuardusUS Endoscopy007111462020-03-19
00724995183622GuardusUS Endoscopy007111472020-03-19
00724995183639GuardusUS Endoscopy007111482020-03-19
00724995183646GuardusUS Endoscopy007111492020-03-19
00724995184513GuardusUS EndoscopySI7111492020-04-02
00816765010631ReachUS Endoscopy007121402016-09-17
00816765011195EntradaUS Endoscopy007111452016-09-17
00816765011201GuardusUS Endoscopy007111462016-09-17
00816765011218GuardusUS Endoscopy007111472016-09-17
00816765011225GuardusUS Endoscopy007111482016-09-17
00816765011232GuardusUS Endoscopy007111492016-09-17
04547410484687FUJIFILMFUJIFILM CORPORATIONTR-1208A2023-10-23
04547410484717FUJIFILMFUJIFILM CORPORATIONTR-1507A2023-10-23
04547410484748FUJIFILMFUJIFILM CORPORATIONTR-1504A2023-10-23
04547410514056FUJIFILMFUJIFILM CORPORATIONTS-1214C2024-07-05
04953170237201SINGLE USE SPLINTING TUBEOLYMPUS MEDICAL SYSTEMS CORP.ST-SB12016-09-21
05425029282018endomina platformEndo Tools Therapeuticsendomina platform2022-07-19