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510(k) K011040

CRYOCARE CARDIAC SURGICAL SYSTEM by Endocare, Inc. — Product Code OCL

K011040 is an FDA 510(k) premarket notification submitted by Endocare, Inc. for the device "CRYOCARE CARDIAC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 15, 2001. The device falls under product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue), a Class II device regulated under 21 CFR 878.4400. Endocare, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2001
Date Received
April 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device Class
Class II
Regulation Number
878.4400
Review Panel
CV
Submission Type

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

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)
  • 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)

Other clearances for product code OCL

  • K252056 — Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (July 24, 2025)
  • K234151 — Isolator Synergy EnCapture Ablation System (EMH) (August 27, 2024)
  • K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® L (December 30, 2022)
  • K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 (December 22, 2022)
  • K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (July 26, 2021)
  • K211311 — AtriCure Isolator® Synergy™ Surgical Ablation System (May 28, 2021)
  • K200514 — Cardioblate Gemini-s Surgical Ablation Device (June 3, 2020)
  • K193162 — EPi-Sense Guided Coagulation System with VisiTrax (December 13, 2019)
  • K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (November 4, 2019)
  • K191526 — Cardioblate CryoFlex Surgical Ablation System (October 1, 2019)

FDA data resources