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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 K232809
FOIA Releasable 510(k) K232809
Device Name Cross Vascular RF Generator and Footswitch (optional accessory)
Applicant
Cross Vascular Inc.
535 Stevens Ave West
Solana Beach,  CA  92075
Applicant Contact Jennifer Willner
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/12/2023
Decision Date 10/12/2023
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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