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 Device, Surgical, Cryogenic
510(k) Number K220656
Device Name iovera System
Applicant
Pacira Biosciences, Inc.
10450 Science Center Dr.
San Diego,  CA  92121
Applicant Contact Danny Rivera
Correspondent
Pacira Biosciences, Inc.
10450 Science Center Dr.
San Diego,  CA  92121
Correspondent Contact Danny Rivera
Regulation Number882.4250
Classification Product Code
GXH  
Subsequent Product Code
ETN  
Date Received03/07/2022
Decision Date 05/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-