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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 K003897
Device Name ENDIUS BIPOLAR SHEATH
Applicant
Endius, Inc.
23 W. Bacon St.
Plainville,  MA  02762
Applicant Contact SUSAN FINNERAN
Correspondent
Endius, Inc.
23 W. Bacon St.
Plainville,  MA  02762
Correspondent Contact SUSAN FINNERAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/18/2000
Decision Date 03/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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