510(k) K262874
K262874 is an FDA 510(k) premarket notification submitted by CraniUS, LLC for the device "CraniUS Plate". The FDA issued a decision of Substantially Equivalent on September 11, 2026. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. CraniUS, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2026
- Date Received
- August 14, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Alterable
- Device Class
- Class II
- Regulation Number
- 882.5320
- Review Panel
- NE
- Submission Type