510(k) K261997
K261997 is an FDA 510(k) premarket notification submitted by Medivis, Inc. for the device "NeuroAlign". The FDA issued a decision of Substantially Equivalent on Oct 26, 2026. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Medivis, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 26, 2026
- Date Received
- Jun 15, 2026
- 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
- 510(k)