FDA.reportPublic FDA data

Gastric calibration tube

Definition
A thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.
GUDID devices
40
Last updated
2026-09-04 23:10:02

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
G461CEGCT40M0EndolumikEndolumik, Inc.CEGCT40M2026-08-25
00851677007058Standard BougieSTANDARD BARIATRICS, INCSB18-12020-04-27
00851677007065Standard Bougie, 38FrSTANDARD BARIATRICS, INCSB382021-08-18
00851677007119Standard Bougie HandpumpSTANDARD BARIATRICS, INCSBHP2021-12-22
00851677007126Standard Tapered Bougie, 38FrSTANDARD BARIATRICS, INCSTB382022-11-28
10811955020022LAP-BAND Calibration TubeApollo Endosurgery, Inc.A-20172014-08-26
10811955020039Gastric Balloon Suction CatheterApollo Endosurgery, Inc.B-20202014-08-26
10816286020598BOEHRINGER® ViSiGi 3D™ Calibration System for Roux-en-y, size 32FrBOEHRINGER LABORATORIES, LLC52322016-08-01
10816286020604BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36FrBOEHRINGER LABORATORIES, LLC52362016-08-01
10816286020635BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr w/bulbBOEHRINGER LABORATORIES, LLC5236B2016-08-01
10816286020642BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 40Fr w/bulbBOEHRINGER LABORATORIES, LLC5240B2016-08-01
10816286020734BOEHRINGER® ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration Sys, size 36FrBOEHRINGER LABORATORIES, LLC5236LS2017-05-01
10816286020826BOEHRINGER® ViSiGi 3D® Calibration System size 32Fr Bypass/ShortBOEHRINGER LABORATORIES, LLC5232S2018-07-01
10816286020833BOEHRINGER® ViSiGi 3D® Calibration System size 36Fr Bypass/ShortBOEHRINGER LABORATORIES, LLC5236S2018-07-01
10816286020840BOEHRINGER® ViSiGi 3D® Calibration System size 40Fr Bypass/ShortBOEHRINGER LABORATORIES, LLC5240S2018-07-01
10816286020857BOEHRINGER® ViSiGi 3D® Calibration System size 32Fr Bypass/Short w/bulbBOEHRINGER LABORATORIES, LLC5232SB2019-03-01
10816286020864BOEHRINGER® ViSiGi 3D® Calibration System size 36Fr Bypass/Short w/bulbBOEHRINGER LABORATORIES, LLC5236SB2019-03-01
10816286021120BOEHRINGER® ViSiGi Lux 36 FrBOEHRINGER LABORATORIES, LLC5336SB2025-05-20
10816286021137BOEHRINGER® ViSiGi Lux 40 FrBOEHRINGER LABORATORIES, LLC5340SB2025-05-20
10884521517370GastriSailCovidien LPGPS362016-10-19
10884521517387GastriSailCovidien LPGPS402016-10-17
20705036003974N/AObtech Medical SàrlRGCT1802016-07-15
20705036003981N/AObtech Medical SàrlRGCT3602016-07-15
G461EGCT360EndolumikEndolumik, Inc.EGCT362023-05-15
G461EGCT36M0EndolumikEndolumik, Inc.EGCT36M2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.EGCT40M2024-08-06
00850007764470ReShape Calibration Tubes™Medtimo, IncB-20172025-08-01
20884521517377GastriSailCovidien LPGPS362016-10-19
30816286021124BOEHRINGER® ViSiGi Lux 36 FrBOEHRINGER LABORATORIES, LLC5336SB2025-05-20
30816286021131BOEHRINGER® ViSiGi Lux 40 FrBOEHRINGER LABORATORIES, LLC5340SB2025-05-20
G461EGCT36M1EndolumikEndolumik, Inc.EGCT36M2024-08-06
G461EGCT40M1EndolumikEndolumik, Inc.EGCT40M2024-08-06
00851677007171Standard Precision Bougie DeviceSTANDARD BARIATRICS, INCSTB382024-07-03
10641043885017Hand Pump AssemblyMERCURY ENTERPRISES, INC.88-GCT5012023-06-15
G461EGCT361EndolumikEndolumik, Inc.EGCT362023-05-15
G461EGCT400EndolumikEndolumik, Inc.EGCT402023-05-15
00850007764258ReShape Calibration TubesMedtimo, IncB-20322023-03-16
00850007764265ReShape Calibration TubesMedtimo, IncB-20362023-03-16
00850007764272ReShape Calibration TubesMedtimo, IncB-20402023-03-16
10851677007123Standard Tapered Bougie, 38FrSTANDARD BARIATRICS, INCSTB382022-11-28