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 Dislodger, Stone, Basket, Ureteral, Metal
510(k) Number K172299
Device Name Accordion Piccolo Stone Management Device
Applicant
THS International, Inc. d/b/a Accordion Medical
9465 Counselors Row, Suite 200
Indianapolis,  IN  46240
Applicant Contact David Quigley
Correspondent
THS International, Inc. d/b/a Accordion Medical
9465 Counselors Row, Suite 200
Indianapolis,  IN  46240
Correspondent Contact David Quigley
Regulation Number876.4680
Classification Product Code
FFL  
Date Received07/31/2017
Decision Date 09/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-