510(k) K254163
K254163 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "VarioSurg 4". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2025
- Date Received
- December 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Drill, Bone, Powered
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type