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
49
Last updated
2025-08-05 15:51:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00191506049379OverTube™BOSTON SCIENTIFIC CORPORATIONM005055602025-07-28
04547410543858FUJIFILMFUJIFILM CORPORATIONTR-1108A2025-02-12
14547410514053FUJIFILMFUJIFILM CORPORATIONTS-1214C2024-07-05
00854172008254EndoRotor® Catheter GuideINTERSCOPE, INCCATHGUIDE2024-02-09
00850006222025Pathfinder® Endoscope Overtube with BalloonNEPTUNE MEDICAL INC.GI 110140B-12023-11-20
00850006222124Pathfinder® Endoscope Overtube with BalloonNEPTUNE MEDICAL INC.GI 085140B-12023-11-20
10860006600805AncoraAspero Medical, Inc.Ancora-SB 4-pack2023-10-26
14547410484684FUJIFILMFUJIFILM CORPORATIONTR-1208A2023-10-23
14547410484714FUJIFILMFUJIFILM CORPORATIONTR-1507A2023-10-23
14547410484745FUJIFILMFUJIFILM CORPORATIONTR-1504A2023-10-23
10811955020695OverTube Endoscopic Access SystemApollo Endosurgery, Inc.OVT-S27-1602016-08-17
10811955020701OverTube Endoscopic Access SystemApollo Endosurgery, Inc.OVT-027-1602016-08-17
04547410467260FUJIFILMFUJIFILM CORPORATIONTS-1314B2023-02-06
05425029282070endomina systemEndo Tools Therapeuticsendomina system2022-07-19
05425029282117endomina platformEndo Tools Therapeuticsendomina platform2022-07-19
00850006222049Pathfinder® Endoscope OvertubeNEPTUNE MEDICAL INC.GI 065110-22021-08-31
00850006222056Pathfinder® Endoscope OvertubeNEPTUNE MEDICAL INC.GI 085110-22021-08-31
00850006222063Pathfinder® Endoscope OvertubeNEPTUNE MEDICAL INC.GI 145110-22021-08-31
00850006222070Pathfinder® Endoscope OvertubeNEPTUNE MEDICAL INC.GI 065140-22021-06-07
00850006222087Pathfinder® Endoscope OvertubeNEPTUNE MEDICAL INC.GI 110140-22021-06-07
00850006222094Pathfinder® Endoscope OvertubeNEPTUNE MEDICAL INC.GI 065160-22021-06-07
00850006222100Pathfinder® Endoscope OvertubeNEPTUNE MEDICAL INC.GI 085160-22021-06-07
00850006222117Pathfinder® Endoscope OvertubeNEPTUNE MEDICAL INC.GI 110160-22021-06-07
00850006222018PathfinderNEPTUNE MEDICAL INC.GI 085140-22021-01-28
00850006222001Pathfinder®NEPTUNE MEDICAL INC.GI 0851402020-07-20
00724995184483GuardusUS EndoscopySI7111462020-04-02
00724995184490GuardusUS EndoscopySI7111472020-04-02
00724995184506GuardusUS EndoscopySI7111482020-04-02
10724995183612GuardusUS Endoscopy007111462020-03-19
10724995183629GuardusUS Endoscopy007111472020-03-19
10724995183636GuardusUS Endoscopy007111482020-03-19
10724995183643GuardusUS Endoscopy007111492020-03-19
10816765012021GuardusUS EndoscopySI7111462016-09-17
10816765012038GuardusUS EndoscopySI7111472016-09-17
10816765012045GuardusUS EndoscopySI7111482016-09-17
10816765012052GuardusUS EndoscopySI7111492016-09-17
04545499070098Flexible OvertubeSB-KAWASUMI LABORATORIES, INC.MD-487192019-09-23
04547410331493FUJIFILMFUJIFILM CORPORATIONTS-121402016-10-18
04547410331509FUJIFILMFUJIFILM CORPORATIONTS-131012016-10-18
04547410331516FUJIFILMFUJIFILM CORPORATIONTS-131402016-10-18
00867630000202Endo-Ease Vista RetrogradeSPIRUS MEDICAL LLCEEV-2002016-09-23
00867630000219Endo-Ease Discovery Low ProfileSPIRUS MEDICAL LLCEED-2502016-09-23
00867630000226Endo-Ease Discovery Standard ProfileSPIRUS MEDICAL LLCEED-3002016-09-23
10816765010638ReachUS Endoscopy007121402016-09-17
10816765011192EntradaUS Endoscopy007111452016-09-17
10816765011208GuardusUS Endoscopy007111462016-09-17
10816765011215GuardusUS Endoscopy007111472016-09-17
10816765011222GuardusUS Endoscopy007111482016-09-17
10816765011239GuardusUS Endoscopy007111492016-09-17