Medical Device Manufacturer · US , Irvine , CA

Endocare, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1996

Recent clearances: CRYOCARE CS SURGICAL SYSTEM, CRYOCARE CN2 SYSTEM, CRYOCARE CS SURGICAL SYSTEM

22
Total
22
Cleared
0
Denied

Endocare, Inc. has 22 FDA 510(k) cleared medical devices. Based in Irvine, US.

Historical record: 22 cleared submissions from 1996 to 2010. Primary specialty: General & Plastic Surgery.

Browse the FDA 510(k) cleared devices submitted by Endocare, Inc. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Tuv America, Inc., Regulatory Technology Services, LLC and Underwriters Laboratories, Inc..

FDA 510(k) Regulatory Record - Endocare, Inc.

22 devices
1-22 of 22
Cleared Jun 14, 2010
CRYOCARE CS SURGICAL SYSTEM
K101333 · GEH
General & Plastic Surgery · 33d
Cleared Aug 28, 2006
CRYOCARE CN2 SYSTEM
K062175 · GEH
General & Plastic Surgery · 28d
Cleared Feb 28, 2006
CRYOCARE CS SURGICAL SYSTEM
K060279 · GEH
General & Plastic Surgery · 26d
Cleared Feb 25, 2005
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
K050347 · GEH
Radiology · 14d
Cleared Aug 12, 2003
CRYOCARE CS SURGICAL SYSTEM
K032333 · GEH
Radiology · 14d
Cleared Dec 05, 2002
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
K023757 · GEH
General & Plastic Surgery · 27d
Cleared Jun 06, 2002
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
K021010 · OCL
Cardiovascular · 69d
Cleared Feb 05, 2002
ERECAID CLASSIC SYSTEM
K020082 · LKY
Gastroenterology & Urology · 26d
Cleared Jan 25, 2002
CRYOCARE SURGICAL SYSTEM
K011074 · GEH
General & Plastic Surgery · 291d
Cleared Oct 11, 2001
CRYOCARE SURGICAL SYSTEM
K003811 · GEH
General & Plastic Surgery · 304d
Cleared Jun 15, 2001
CRYOCARE CARDIAC SURGICAL SYSTEM
K011040 · OCL
Cardiovascular · 71d
Cleared May 03, 2001
SANARUS CORE TISSUE BIOPSY SYSTEM
K003528 · KNW
Gastroenterology & Urology · 168d
Cleared Mar 07, 2001
ENDOCARE PERCUTANEOUS ACCESS SET
K010339 · KOD
Gastroenterology & Urology · 30d
Cleared Nov 13, 2000
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · GEH
General & Plastic Surgery · 83d
Cleared Oct 13, 2000
ENDOCARE PERCUTANEOUS ACCESS SET
K002396 · KOD
Gastroenterology & Urology · 67d
Cleared Apr 10, 1998
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
K980110 · GEH
General & Plastic Surgery · 88d
Cleared Dec 22, 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM
K973686 · GEH
General & Plastic Surgery · 87d
Cleared Feb 25, 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
K963970 · GEH
General & Plastic Surgery · 145d
Cleared Feb 25, 1997
ENDOCARE MONOPOLAR ELECTRODE
K965118 · FAS
Gastroenterology & Urology · 67d
Cleared Feb 25, 1997
ENDOCARE ELECTROSURGICAL ELECTRODE
K965243 · GEI
General & Plastic Surgery · 64d
Cleared Dec 18, 1996
ENDOCARE CRYCARE CRYOSURGICAL SYSTEM
K963826 · GEH
General & Plastic Surgery · 84d
Cleared Aug 15, 1996
ENDOCARE ELECTORNIC THERMOMETER SYSTEM
K961365 · FLL
General Hospital · 128d
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