# Endocare, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 22 (1996–2010): 22 510(k) clearances
- Product codes: GEH (13), OCL (2), KOD (2), FLL (1), LKY (1), GEI (1), KNW (1), FAS (1)
- Predicates its devices cite: 23 (9 its own); citations of its devices by later devices: 34 (9 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cryomedical Sciences, Inc.: 5 (https://510kreport.com/company/cryomedical-sciences)
- Cytocare, Inc.: 4 (https://510kreport.com/company/cytocare)
- Teratech Corp.: 3 (https://510kreport.com/company/teratech)
- Uros Corp.: 1 (https://510kreport.com/company/uros)
- Electromedics, Inc.: 1 (https://510kreport.com/company/electromedics)

## Firms that cite its devices most
- Cryocath Technologies, Inc.: 6 (https://510kreport.com/company/cryocath-technologies)
- Misonix, Inc.: 4 (https://510kreport.com/company/misonix)
- Healthtronics: 3 (https://510kreport.com/company/healthtronics)
- Sanarus Medical, Inc.: 2 (https://510kreport.com/company/sanarus-medical)
- Vivant Medical, Inc.: 1 (https://510kreport.com/company/vivant-medical)
- AtriCure, Inc.: 1 (https://510kreport.com/company/atricure)
- UC-CARE, Ltd.: 1 (https://510kreport.com/company/uc-care)
- Neuwave Medical, Inc.: 1 (https://510kreport.com/company/neuwave-medical)

## Its most-cited devices
- K011040: Cryocare Cardiac Surgical System (2001), cited by 5
- K021010: Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE (2002), cited by 3
- K011074: Cryocare Surgical System (2002), cited by 3
- K003811: Cryocare Surgical System (2001), cited by 3
- K032333: Cryocare CS Surgical System (2003), cited by 2
- K961365: Endocare Electornic Thermometer System (1996), cited by 2

## Recent decisions
- K101333: Cryocare CS Surgical System (Jun 14, 2010)
- K062175: Cryocare CN2 System (Aug 28, 2006)
- K060279: Cryocare CS Surgical System (Feb 28, 2006)
- K050347: Modification to Cryocare CS Surgical System (Feb 25, 2005)
- K032333: Cryocare CS Surgical System (Aug 12, 2003)
- K023757: Cryocare Surgical System, Model Cryo 20 (Dec 5, 2002)
- K021010: Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE (Jun 6, 2002)
- K020082: Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery System (Feb 5, 2002)

Source page: https://510kreport.com/company/endocare