510(k) K250815
K250815 is an FDA 510(k) premarket notification submitted by Hubly, Inc. for the device "Hubly Drill (H100)". The FDA issued a decision of Substantially Equivalent on November 6, 2025. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Hubly, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2025
- Date Received
- March 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Device Class
- Class II
- Regulation Number
- 882.4310
- Review Panel
- NE
- Submission Type