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 K261448
Device Name neXus Ultrasonic Surgical Aspirator System
Applicant
Misonix, LLC
1938 New Hwy.
Farmingdale,  NY  11735
Applicant Contact Shreyash Jalgaonkar
Correspondent
Misonix, LLC
1938 New Hwy.
Farmingdale,  NY  11735
Correspondent Contact Shreyash Jalgaonkar
Classification Product Code
LFL  
Subsequent Product Code
GEI  
Date Received05/01/2026
Decision Date 07/30/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-