FDA.reportPublic FDA data

Flexible video gastroscope, single-use

Definition
An endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a single-use device.
GUDID devices
12
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05707480148172aScope™ GastroAmbu A/S483001000US2022-04-16
05707480161850Ambu® aScope™ Gastro LargeAmbu A/S5821010002024-04-17
04547410529128FUJIFILMFUJIFILM CORPORATIONEG-S100XT2026-05-22
06972520301094REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.RP-GI-G02A2024-09-02
06972520301100REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.RP-GI-G02B2024-09-02
00850031897076Single-Use Gastroscope 3.5/2.0 85cmEvoendo, Inc.LE 2024-08-30
00850031897083Single-Use Gastroscope 3.5/2.0 85cm 5-packEvoendo, Inc.LE2024-08-30
00850031897090Single-Use Gastroscope 3.5/2.0 85cm DEMOEvoendo, Inc.LE2024-08-30
05707480161867Ambu® aScope™ Gastro LargeAmbu A/S5821010002024-04-17
05707480148165aScope™ GastroAmbu A/S483001000US2022-04-16
00850031897014EvoEndo Model LE Single-Use GastroscopeEvoendo, Inc.LE2022-02-25
00850031897038EvoEndo Model LE Single-Use GastroscopeEvoendo, Inc.LE2022-02-25