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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 K193018
Device Name Surgical Direct Hand-held Laparoscopic Instruments
Applicant
Surgical Direct, Inc.
909 S. Woodland Blvd.
Deland,  FL  32720
Applicant Contact David Murray
Correspondent
Smith Associates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E. J. Smith
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/29/2019
Decision Date 12/20/2019
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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