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 suture, absorbable, synthetic, polyglycolic acid
510(k) Number K192580
Device Name STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
Applicant
Ethicon, Inc
Route 22 West, P.O. Box 151
Somerville,  NJ  00876 -0151
Applicant Contact Eleanor Zhou
Correspondent
Ethicon, Inc
Route 22 West, P.O. Box 151
Somerville,  NJ  00876 -0151
Correspondent Contact Eleanor Zhou
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/19/2019
Decision Date 12/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
-
-