510(k) clearances

Surgical Power System

Guizhou Zirui Technology Co., Ltd. · Neurology

K254174Substantially EquivalentTraditionalHBC
Open FDA's page for this record
Third party flag
N
City
Zunyi
Advisory committee description
Neurology
Address 1
2f&3f, Bldg. B, Phase 1, Guizhou Loushanguan High-Tech
Address 2
Industrial Development Zone, Chumi Town, Tongzi County
Statement or summary
Summary
Product code
HBC
Zip code
563200
Applicant
Guizhou Zirui Technology Co., Ltd.
Decision date
2026-09-11
Decision code
SESE
Country code
CN
Device name
Surgical Power System
Advisory committee
NE
Contact
Chang Feng Liu
K number
K254174
Date received
2025-12-23
Review advisory committee
NE
Postal code
563200
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Motor, Drill, Electric
Medical specialty description
Neurology
Regulation number
882.4360
Device class
2
Registration number
3007997036, 3007958831, 1723170, 3014479313, 9610612, 3017210488, 3001239363, 3045751639, 1834331, 1045254, 1625507, 3005382983, 2648666, 3018994966, 3007456622, 3025603301, 1220477, 9612501, 1526611, 3009417901, 1649518, 1045834, 3004598644, 1526534, 2916714, 3007305485, 3010163695, 3015453963, 1048735, 2647346, 9611253, 1061124, 1058584, 3003800209, 3025764223, 1222928, 3012607373, 3036756245, 3002808022, 1319639 +10 more
FEI number
3007997036, 3007958831, 1000517638, 3002806315, 3002807687, 3014479313, 3017210488, 3001239363, 3003128516, 3045751639, 3005601686, 1045254, 1625507, 3005382983, 2648666, 3018994966, 1000306340, 3007456622, 3025603301, 1220477, 1526611, 3009417901, 1045834, 3004598644, 1526534, 1000120613, 2916714, 3007305485, 3010163695, 3015453963, 1048735, 2647346, 1000219637, 3003495548, 3003800209, 3025764223, 3001236277, 3012607373, 3036756245, 3002808022 +10 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.