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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 K252083
Device Name HOTWIRE™ System RF Generator and Footswitch (optional accessory)
Applicant
Atraverse Medical, Inc.
2611 S Coast Hwy 101 #204
Cardiff By The Sea,  CA  92007
Applicant Contact Charles Yang
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/02/2025
Decision Date 08/12/2025
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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