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 K182080
Device Name Scope Antifogging System
Applicant
Xodus Medical, Inc.
702 Prominence Drive
New Kensington,  PA  15068
Applicant Contact Paul Lloyd
Correspondent
Xodus Medical, Inc.
702 Prominence Drive
New Kensington,  PA  15068
Correspondent Contact Paul Lloyd
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
OCT  
Date Received08/02/2018
Decision Date 09/19/2018
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
-
-