510(k) clearance
Rapid Barostat Bag (RBB) Pump and Catheter System
- 510(k) number
- K262621
- Applicant
- Mui Scientific, Inc.
- Decision date
- Sep 30, 2026
- Date received
- Jul 28, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- FFX
- Device type
- System, Gastrointestinal Motility (Electrical)
- Device class
- Class II
- Regulation
- 21 CFR 876.1725
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Mississauga, CA