Rapid Barostat Bag (RBB) Pump and Catheter System
Mui Scientific, Inc. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Mississauga
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 145 Traders Blvd. E.,
- Address 2
- Unit #34
- Statement or summary
- Summary
- Product code
- FFX
- Zip code
- L4Z 3L3
- Applicant
- Mui Scientific, Inc.
- Decision date
- 2026-09-30
- Decision code
- SESE
- Country code
- CA
- Device name
- Rapid Barostat Bag (RBB) Pump and Catheter System
- Advisory committee
- GU
- Contact
- Fatemeh Rahimi
- K number
- K262621
- Date received
- 2026-07-28
- Review advisory committee
- GU
- Postal code
- L4Z 3L3
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- System, Gastrointestinal Motility (Electrical)
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1725
- Device class
- 2
- Registration number
- 3017448360, 3008717264, 9611668, 3002821211, 2023374, 3035451914, 9681384, 3004904811, 3010082909, 3016544248, 3011790297, 3009445917, 3009106214, 9611896, 8020893, 1126271, 3012480535, 3007662958, 1836324, 9710107, 1000562786, 1119033, 3015198783, 3008361498, 3002806603, 3013973539, 3016854619, 1123137, 3010381606, 3008414621, 3018094310, 3012302888
- FEI number
- 3017448360, 3008717264, 3002821211, 3018094310, 2023374, 3035451914, 3004904811, 3010082909, 1000123180, 3016544248, 3011790297, 3009106214, 3012480535, 3007662958, 3003348376, 3002807626, 1000562786, 3002957361, 1119033, 3009293069, 3015198783, 3002807135, 3008361498, 3002807850, 3002806603, 3013973539, 3016854619, 1000263641, 3010381606, 3008414621, 3002998595, 3012302888