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 Hemostatic Metal Clip For The Gi Tract
510(k) Number K201808
Device Name X-Tack Endoscopic HeliX Tacking System
Applicant
Apollo Endosurgery, Inc.
1120 S. Capital Of Texas Hwy
Austin,  TX  78749
Applicant Contact Natalie Allen
Correspondent
Apollo Endosurgery, Inc.
1120 S. Capital Of Texas Hwy
Austin,  TX  78749
Correspondent Contact Natalie Allen
Regulation Number876.4400
Classification Product Code
PKL  
Subsequent Product Code
OCW  
Date Received07/01/2020
Decision Date 12/15/2020
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
-
-