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 Laparoscope, General & Plastic Surgery
510(k) Number K212214
Device Name HandX
Applicant
Human Xtensions Ltd.
4 Meir Ariel St.
Netanya,  IL 4250574
Applicant Contact Maija Wallenstein
Correspondent
Hogan Lovells US LLP
Columbia Square 555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact Randy J Prebula
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
NAY  
Date Received07/15/2021
Decision Date 09/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-