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 Mesh, Surgical, For Stress Urinary Incontinence, Male
510(k) Number K182169
Device Name AdVance XP Male Sling
Applicant
Boston Scientific Corporation
10700 Bren Rd. W.
Minnetonka,  MN  55343
Applicant Contact Kaitlyn Rainbow
Correspondent
Boston Scientific Corporation
10700 Bren Rd. W.
Minnetonka,  MN  55343
Correspondent Contact Kaitlyn Rainbow
Regulation Number878.3300
Classification Product Code
OTM  
Date Received08/10/2018
Decision Date 11/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-