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 electrosurgical, cutting & coagulation & accessories
510(k) Number K181852
Device Name Percuvance Percutaneous Surgical System
Applicant
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact Kim Campbell
Correspondent
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact Kim Campbell
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
GCJ   GDO  
Date Received07/11/2018
Decision Date 10/12/2018
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
-
-