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510(k) K101825

CRYOBALLOON ABLATION SYSTEM by C2 Therapeutics — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2010
Date Received
July 1, 2010
Clearance Type
Traditional
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 C2 Therapeutics

  • K163684 — C2 CryoBalloon Ablation System (January 23, 2018)
  • K161202 — C2 Cryoballoon Ablation System (January 5, 2017)
  • K160994 — C2 CryoBalloon Focal Pear Catheter (May 19, 2016)
  • K152329 — Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablatio (April 13, 2016)
  • K153541 — Coldplay CryoBalloon® Ablation System (January 7, 2016)
  • K152140 — Boa Endoscopic Valve (October 13, 2015)
  • K151054 — Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablatio (July 7, 2015)
  • K150083 — Sidecar External Working Channel (April 14, 2015)
  • K131523 — CRYOBALLOON FOCAL ABLATION SYSTEM (August 22, 2013)

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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)