• 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, nonabsorbable, synthetic, polyethylene
510(k) Number K231163
Device Name HS Fiber Sutures
Applicant
Riverpoint Medical
825 NE 25th Ave
Portland,  OR  97232
Applicant Contact Paul Vagts
Correspondent
Riverpoint Medical
825 NE 25th Ave
Portland,  OR  97232
Correspondent Contact Paul Vagts
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
LPL  
Date Received04/24/2023
Decision Date 01/05/2024
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 No
-
-