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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K261068
Device Name Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
Applicant
Serpex Medical
3350 Scott Blvd.
Suite 37b
Santa Clara,  CA  95054
Applicant Contact Neil Zimmerman
Correspondent
Serpex Medical
3350 Scott Blvd.
Suite 37b
Santa Clara,  CA  95054
Correspondent Contact Krystal Santiago
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/01/2026
Decision Date 06/30/2026
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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