510(k) K251317
K251317 is an FDA 510(k) premarket notification submitted by Intravent Medical Partners for the device "SOLOPASS 2.0 System". The FDA issued a decision of Substantially Equivalent on September 5, 2025. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Intravent Medical Partners has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2025
- Date Received
- April 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type