Home / 510(k) Clearances / K023757

510(k) K023757

CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 by Endocare, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2002
Date Received
November 8, 2002
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 Endocare, Inc.

  • K101333 — CRYOCARE CS SURGICAL SYSTEM (June 14, 2010)
  • K062175 — CRYOCARE CN2 SYSTEM (August 28, 2006)
  • K060279 — CRYOCARE CS SURGICAL SYSTEM (February 28, 2006)
  • K050347 — MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM (February 25, 2005)
  • K032333 — CRYOCARE CS SURGICAL SYSTEM (August 12, 2003)
  • K021010 — MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE (June 6, 2002)
  • K020082 — ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYS (February 5, 2002)
  • K011074 — CRYOCARE SURGICAL SYSTEM (January 25, 2002)
  • K003811 — CRYOCARE SURGICAL SYSTEM (October 11, 2001)
  • K011040 — CRYOCARE CARDIAC SURGICAL SYSTEM (June 15, 2001)

Other clearances for product code GEH

  • K260377 — XSense Cryoablation System with CryoProbes (February 24, 2026)
  • K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control (February 13, 2026)
  • K251524 — Dr. Yglo Skin Tag Remover (January 12, 2026)
  • K250742 — Focused Cryotherapy System (December 9, 2025)
  • K253000 — CryoFreeze Wart and Skin Tag Remover (October 16, 2025)
  • K253114 — TargetCool™ (RM-DT02W) (October 16, 2025)
  • K253348 — TargetCool-e (October 15, 2025)
  • K252903 — Verruca-Freeze H Plus (October 10, 2025)
  • K251493 — Skin Clinic Freeze Point for Warts and Skin Tags (May 22, 2025)
  • K242932 — Skin Clinic Nitro Clear Wart Remover (April 15, 2025)