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510(k) K032333

CRYOCARE CS SURGICAL SYSTEM by Endocare, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2003
Date Received
July 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K023757 — CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 (December 5, 2002)
  • 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)

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