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 K212329
Device Name Plasma IQ
Applicant
Neauvia North America, Inc.
8480 Honeycutt Rd.
Raliegh,  NC  27615
Applicant Contact Joy Willard
Correspondent
Neauvia North America, Inc.
8480 Honeycutt Rd.
Raliegh,  NC  27615
Correspondent Contact Joy Willard
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/27/2021
Decision Date 12/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-