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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 K252316
Device Name Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
Applicant
Venclose, Inc.
2570 N. First St.
2nd Floor #221
San Jose,  CA  95131
Applicant Contact Kulveen Dhatt
Correspondent
Venclose, Inc.
2570 N. First St.
2nd Floor #221
San Jose,  CA  95131
Correspondent Contact Kulveen Dhatt
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/25/2025
Decision Date 08/19/2025
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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