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 instrument, ultrasonic surgical
510(k) Number K172595
Device Name CUSA Excel+ Ultrasonic Surgical Aspirator System
Applicant
Integra LifeSciences Corporation
311 Enterprise Drive
PLAINSBORO,  NJ  08536
Applicant Contact Alexandra Wells
Correspondent
Integra LifeSciences Corporation
311 Enterprise Drive
PLAINSBORO,  NJ  08536
Correspondent Contact Alexandra Wells
Classification Product Code
LFL  
Subsequent Product Code
LBK  
Date Received08/29/2017
Decision Date 09/28/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-