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510(k) K162695

truFreeze System by CSA Medical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2016
Date Received
September 27, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by CSA Medical, Inc.

  • K201183 — Vortex Radial Spray Catheter (December 7, 2020)
  • K171626 — truFreeze System (August 30, 2017)
  • K172041 — truFreeze System (July 27, 2017)
  • K171522 — truFreeze Rapid AV Spray Kit (July 14, 2017)
  • K163244 — truFreeze System (May 24, 2017)
  • K161557 — truFreeze System (July 26, 2016)
  • K152668 — truFreeze System (October 14, 2015)
  • K150920 — truFreeze System (June 17, 2015)
  • K143625 — truFreeze System (January 15, 2015)
  • K133258 — TRUFREEZE SYSTEM (June 19, 2014)

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  • K251493 — Skin Clinic Freeze Point for Warts and Skin Tags (May 22, 2025)
  • K242932 — Skin Clinic Nitro Clear Wart Remover (April 15, 2025)