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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
510(k) Number K020126
Device Name MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)
Applicant
Surx, Inc.
2675 Collier Canyon Rd.
Livermore,  CA  94550
Applicant Contact ALAN CURTIS
Correspondent
Surx, Inc.
2675 Collier Canyon Rd.
Livermore,  CA  94550
Correspondent Contact ALAN CURTIS
Regulation Number878.4400
Classification Product Code
MUK  
Date Received01/15/2002
Decision Date 03/15/2002
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
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