Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Drills, Burrs, Trephines & Accessories (Compound, Powered)
510(k) Number K254177
Device Name Disposable Sterile Skull Drill (LZ)
Applicant
Guizhou Zirui Technology Co., Ltd.
2f&3f, Bldg. B, Phase 1, Guizhou Loushanguan High-Tech
Industrial Development Zone, Chumi Town, Tongzi County
Zunyi,  CN 563200
Applicant Contact Chang Feng Liu
Correspondent
Nanos Medical Shanghai Limited
Rm. 1304, #88 Changning Rd.
Changning District
Shanghai,  CN 200042
Correspondent Contact Yoyo Chen
Regulation Number882.4305
Classification Product Code
HBF  
Date Received12/23/2025
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-