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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 K012799
Device Name ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
Applicant
Senorx, Inc.
11 Columbia, Suite A
Aliso Viejo,  CA  92656
Applicant Contact AMY BOUCLY
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DONALD JAMES SHERRATT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/21/2001
Decision Date 09/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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