FDA.report

Rectosphincteric balloon

Definition
A hollow rubber structure, expandable with either liquid or air, used in conjunction with a manometer to assess anorectal function (anorectal manometry), typically to evaluate the rectosphincteric reflex upon balloon dilation. The device is typically used in the investigation of lower bowel disorders such as faecal incontinence or Hirschsprung's disease (HD). This is a single-use device.
GUDID devices
31
Last updated
2025-01-17 16:10:17

Related Product Codes

CodeDeviceSpecialtyClassDevices
KNQDilator, EsophagealGastroenterology, Urology216
PCTProstate Immobilizer Rectal BalloonRadiology29
KLAMonitor, Esophageal Motility, Anorectal Motility, And TubeGastroenterology, Urology26

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
B960RED201REDNeuraxis, Inc.02 2050 RED2025-01-09
00851607003327Single Patient Kit, mcompass, Anorectal Manometry 5-channelMEDSPIRA, LLCRMD-002-0092023-10-06
00851607003334Single Patient Kit, mcompass, Anorectal Manometry 5-channel, PetiteMEDSPIRA, LLCRMD-002-0102023-10-06
10851607003348Single Patient Kit, mcompass, Anorectal Manometry 2-channelMEDSPIRA, LLCRMD-002-0112023-10-06
20851546007091IsoLocRADIADYNE, L.L.C.ISO-602018-01-31
20851607003185mcompass Extension Tube SetMEDSPIRA, LLCRMD-002-0062019-06-25
26932503523077NAMicro-Tech (Nanjing) Co., Ltd.MBD-BM-BB-22016-03-08
26932503523091NAMicro-Tech (Nanjing) Co., Ltd.MBD-CL-BA-22016-03-08
26932503523114NAMicro-Tech (Nanjing) Co., Ltd.MBD-CM-BB-22016-03-08
26932503523138NAMicro-Tech (Nanjing) Co., Ltd.MBD-DL-BA-22016-03-08
26932503523152NAMicro-Tech (Nanjing) Co., Ltd.MBD-DM-BB-22016-03-08
26932503523176NAMicro-Tech (Nanjing) Co., Ltd.MBD-EL-BA-22016-03-08
26932503523190NAMicro-Tech (Nanjing) Co., Ltd.MBD-EM-BB-22016-03-08
26932503523213NAMicro-Tech (Nanjing) Co., Ltd.MBD-FM-BA-22016-03-08
06932503523080NAMicro-Tech (Nanjing) Co., Ltd.MBD-BS-BB-22016-03-08
06932503523103NAMicro-Tech (Nanjing) Co., Ltd.MBD-CM-BA-22016-03-08
06932503523127NAMicro-Tech (Nanjing) Co., Ltd.MBD-CS-BB-22016-03-08
06932503523141NAMicro-Tech (Nanjing) Co., Ltd.MBD-DM-BA-22016-03-08
06932503523165NAMicro-Tech (Nanjing) Co., Ltd.MBD-DS-BB-22016-03-08
06932503523189NAMicro-Tech (Nanjing) Co., Ltd.MBD-EM-BA-22016-03-08
06932503523202NAMicro-Tech (Nanjing) Co., Ltd.MBD-FL-BA-22016-03-08
06932503523226NAMicro-Tech (Nanjing) Co., Ltd.MBD-FM-BB-22016-03-08
20851546007015ImmobiLocRADIADYNE, L.L.C.IL-602016-09-12
20851546007022ImmobiLocRADIADYNE, L.L.C.IL-1002016-09-12
20851546007039ImmobiLocRADIADYNE, L.L.C.ILG-60F2016-09-12
20851546007046ImmobiLocRADIADYNE, L.L.C.ILG-60F-60ml2016-09-12
20851546007053ImmobiLocRADIADYNE, L.L.C.ILG-90F2016-09-12
00851546007092IsoLocRADIADYNE, L.L.C.ISO-602018-01-31
20851546007107IsoLocRADIADYNE, L.L.C.ISO-1002018-01-31
20851546007213IsoLocRADIADYNE, L.L.C.ISO-602018-01-31
20851607003079mcompass Biofeedback 2-Channel CatheterMEDSPIRA, LLCRMD-002-0042017-01-06