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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 K111412
Device Name SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK
Applicant
Steerable Technologix
10302 Deerwood Park Blvd.,
Suite 209
Jacksonville,  FL  32256
Applicant Contact GLEN JORGENSEN
Correspondent
Steerable Technologix
10302 Deerwood Park Blvd.,
Suite 209
Jacksonville,  FL  32256
Correspondent Contact GLEN JORGENSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/20/2011
Decision Date 09/30/2011
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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