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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 K192124
Device Name Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories
Applicant
Us Medical Innovations, LLC
6930 Carroll Ave.
Takoma Park,  MD  20912
Applicant Contact David Hinds
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Tim Joiner
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/06/2019
Decision Date 11/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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