510(k) K262621
K262621 is an FDA 510(k) premarket notification submitted by Mui Scientific, Inc. for the device "Rapid Barostat Bag (RBB) Pump and Catheter System". The FDA issued a decision of Substantially Equivalent on Sep 30, 2026. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Mui Scientific, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2026
- Date Received
- Jul 28, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Gastrointestinal Motility (Electrical)
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type
- 510(k)