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 Endoscopic Tissue Approximation Device
510(k) Number K160149
Device Name Miret Grasper, Alligator, Miret Grasper, Maryland
Applicant
Miret Surgical, Inc.
205 E. Butterfield Rd., Suite 457
Elmhurst,  IL  60126
Applicant Contact AVI ROOP
Correspondent
Edgeone Medical
455 N Campbell Ave., #2n
Chicago,  IL  60612
Correspondent Contact JERZY WOJCIK
Regulation Number876.1500
Classification Product Code
OCW  
Date Received01/21/2016
Decision Date 08/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-