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 System, Surgical, Computer Controlled Instrument
510(k) Number K202166
FOIA Releasable 510(k) K202166
Device Name Senhance Surgical System
Applicant
TransEnterix, Inc.
635 Davis Drive, Suite 300
Morrisville,  NC  27560
Applicant Contact Kaitlyn Alexander
Correspondent
TransEnterix, Inc.
635 Davis Drive, Suite 300
Morrisville,  NC  27560
Correspondent Contact Kaitlyn Alexander
Regulation Number876.1500
Classification Product Code
NAY  
Date Received08/03/2020
Decision Date 03/02/2021
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
Predetermined Change
Control Plan Authorized		 No
-
-