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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 K171717
Device Name AUTOCON III 400
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Applicant Contact AnnaLisa Smullin
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact DAWN M TIBODEAU
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/09/2017
Decision Date 08/02/2017
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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