# Endocare, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Endocare, Inc. is a medical device manufacturer, with 22 devices listed in FDA 510(k) (FDA Class II) and 1 FDA recall as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/endocare-inc>
- Country: United States (FDA applicant, unverified)
- Role: Manufacturer
- DUNS: 928955509

## Figures

- Devices: 22
- FDA recalls (matched to the firm by name): 1

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA 510(k) 22
- Device classes: FDA Class II 22

## Devices

The first 22 of 22, in the order of the canonical page, which lists them all.

- [Cryocare Cardiac Surgical System](https://devicerts.com/devices/cryocare-cardiac-surgical-system-ocl) · ref K011040 · Class II · 510(k) · status: Active · decision 2001-06-15
- [Endocare Crycare Cryosurgical System](https://devicerts.com/devices/endocare-crycare-cryosurgical-system-geh) · ref K963826 · Class II · 510(k) · status: Active · decision 1996-12-18
- [Sanarus Core Tissue Biopsy System](https://devicerts.com/devices/sanarus-core-tissue-biopsy-system-knw) · ref K003528 · Class II · 510(k) · status: Active · decision 2001-05-03
- [Endocare Electornic Thermometer System](https://devicerts.com/devices/endocare-electornic-thermometer-system-fll) · ref K961365 · Class II · 510(k) · status: Active · decision 1996-08-15
- [Cryocare Cs Surgical System](https://devicerts.com/devices/cryocare-cs-surgical-system-geh-k101333) · ref K101333 · Class II · 510(k) · status: Active · decision 2010-06-14
- [Endocare Cryocare Cryosurgical System](https://devicerts.com/devices/endocare-cryocare-cryosurgical-system-geh) · ref K973686 · Class II · 510(k) · status: Active · decision 1997-12-22
- [Endocare Electrosurgical Electrode](https://devicerts.com/devices/endocare-electrosurgical-electrode-gei) · ref K965243 · Class II · 510(k) · status: Active · decision 1997-02-25
- [Endocare Monopolar Electrode](https://devicerts.com/devices/endocare-monopolar-electrode-fas) · ref K965118 · Class II · 510(k) · status: Active · decision 1997-02-25
- [Cryocare Cs Surgical System](https://devicerts.com/devices/cryocare-cs-surgical-system-geh-k032333) · ref K032333 · Class II · 510(k) · status: Active · decision 2003-08-12
- [Cryocare Cs Surgical System](https://devicerts.com/devices/cryocare-cs-surgical-system-geh-k060279) · ref K060279 · Class II · 510(k) · status: Active · decision 2006-02-28
- [Cryocare Surgical System, Model Cryo 20](https://devicerts.com/devices/cryocare-surgical-system-model-cryo-20-geh) · ref K023757 · Class II · 510(k) · status: Active · decision 2002-12-05
- [Surgical System With Cryoguide](https://devicerts.com/devices/surgical-system-with-cryoguide-geh) · ref K002615 · Class II · 510(k) · status: Active · decision 2000-11-13
- [Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery System](https://devicerts.com/devices/erecaid-classic-system-erecaid-esteem-manual-system-erecaid-lky) · ref K020082 · Class II · 510(k) · status: Active · decision 2002-02-05
- [Endocare Percutaneous Access Set](https://devicerts.com/devices/endocare-percutaneous-access-set-kod-k010339) · ref K010339 · Class II · 510(k) · status: Active · decision 2001-03-07
- [Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE](https://devicerts.com/devices/modified-cardiac-cryosurgical-system-models-6tcs1-and-6tcse-ocl) · ref K021010 · Class II · 510(k) · status: Active · decision 2002-06-06
- [Endocre Cryocare Cryosurgical System](https://devicerts.com/devices/endocre-cryocare-cryosurgical-system-geh) · ref K980110 · Class II · 510(k) · status: Active · decision 1998-04-10
- [Cryocare Surgical System](https://devicerts.com/devices/cryocare-surgical-system-geh-k011074) · ref K011074 · Class II · 510(k) · status: Active · decision 2002-01-25
- [Cryocare Surgical System](https://devicerts.com/devices/cryocare-surgical-system-geh) · ref K003811 · Class II · 510(k) · status: Active · decision 2001-10-11
- [Modification To Cryocare Cs Surgical System](https://devicerts.com/devices/modification-to-cryocare-cs-surgical-system-geh) · ref K050347 · Class II · 510(k) · status: Active · decision 2005-02-25
- [Cryocare CN2 System](https://devicerts.com/devices/cryocare-cn2-system-geh) · ref K062175 · Class II · 510(k) · status: Active · decision 2006-08-28
- [Endocare Percutaneous Access Set](https://devicerts.com/devices/endocare-percutaneous-access-set-kod) · ref K002396 · Class II · 510(k) · status: Active · decision 2000-10-13
- [Endocare Cryocare Cryosurgical System Urethral Warming System](https://devicerts.com/devices/endocare-cryocare-cryosurgical-system-urethral-warming-syste-geh) · ref K963970 · Class II · 510(k) · status: Active · decision 1997-02-25

## FDA recalls (matched by name, newest first)

- Z-0728-03 · Unclassified (pre-2012) · Terminated · initiated 2002-10-25 · product code GEH: Device design failure, connectivity.

## Source and citation

- Cite as: Endocare, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/endocare-inc (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/endocare-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/endocare-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.