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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K181852
Device Name Percuvance Percutaneous Surgical System
Applicant
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Kim Campbell
Correspondent
Teleflexmedical, 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
Predetermined Change
Control Plan Authorized		 No
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