Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K262420
Device Name Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
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 Received07/16/2026
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-