510(k) K262744
K262744 is an FDA 510(k) premarket notification submitted by Stereotaxis, Inc. for the device "GenesisX RMN". The FDA issued a decision of Substantially Equivalent on August 27, 2026. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290. Stereotaxis, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2026
- Date Received
- August 3, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Catheter Control, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1290
- Review Panel
- CV
- Submission Type