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 K161792
Device Name PINPOINT Endoscopic Fluorescence Imaging System
Applicant
Novadaq Technologies, Inc.
8329 Eastlake Dr. Unit 101
Burnaby,  CA V5A 4W2
Applicant Contact Jen Pendlebury
Correspondent
Novadaq Technologies, Inc.
8329 Eastlake Dr. Unit 101
Burnaby,  CA V5A 4W2
Correspondent Contact Jen Pendlebury
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
IZI  
Date Received06/30/2016
Decision Date 09/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-