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Endocare, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K101333CRYOCARE CS SURGICAL SYSTEMJune 14, 2010
K062175CRYOCARE CN2 SYSTEMAugust 28, 2006
K060279CRYOCARE CS SURGICAL SYSTEMFebruary 28, 2006
K050347MODIFICATION TO CRYOCARE CS SURGICAL SYSTEMFebruary 25, 2005
K032333CRYOCARE CS SURGICAL SYSTEMAugust 12, 2003
K023757CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20December 5, 2002
K021010MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSEJune 6, 2002
K020082ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEMFebruary 5, 2002
K011074CRYOCARE SURGICAL SYSTEMJanuary 25, 2002
K003811CRYOCARE SURGICAL SYSTEMOctober 11, 2001
K011040CRYOCARE CARDIAC SURGICAL SYSTEMJune 15, 2001
K003528SANARUS CORE TISSUE BIOPSY SYSTEMMay 3, 2001
K010339ENDOCARE PERCUTANEOUS ACCESS SETMarch 7, 2001
K002615SURGICAL SYSTEM WITH CRYOGUIDENovember 13, 2000
K002396ENDOCARE PERCUTANEOUS ACCESS SETOctober 13, 2000
K980110ENDOCRE CRYOCARE CRYOSURGICAL SYSTEMApril 10, 1998
K973686ENDOCARE CRYOCARE CRYOSURGICAL SYSTEMDecember 22, 1997
K965243ENDOCARE ELECTROSURGICAL ELECTRODEFebruary 25, 1997
K965118ENDOCARE MONOPOLAR ELECTRODEFebruary 25, 1997
K963970ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEMFebruary 25, 1997