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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K253777
Device Name Ascblue (8010)
Applicant
Ascblue Corporation
480 Apollo St. Suite D.
Brea,  CA  92821
Applicant Contact Yuexin Guo
Correspondent
Ascblue Corporation
480 Apollo St. Suite D.
Brea,  CA  92821
Correspondent Contact Helen Xie
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/26/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-