510(k) K254174
K254174 is an FDA 510(k) premarket notification submitted by Guizhou Zirui Technology Co., Ltd. for the device "Surgical Power System". The FDA issued a decision of Substantially Equivalent on September 11, 2026. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Guizhou Zirui Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2026
- Date Received
- December 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Electric
- Device Class
- Class II
- Regulation Number
- 882.4360
- Review Panel
- NE
- Submission Type