Identifiers
- 510(k) Number
- K003811 FDA 510(k)
- FDA Product Code
- GEH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4350 FDA 510(k)
- Regulation Number
- 878.4350 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cryocare Surgical System is a cryosurgical unit designed for use in general and plastic surgery procedures. It utilizes cryogenic technology to perform surgical treatments by freezing targeted tissues.
The system is supplied as a reusable device and is not MRI compatible. It is authorized under FDA 510K clearance with product code GEH and is manufactured by Endocare, Inc. in Irvine, California.
Frequently asked questions
What is the Cryocare Surgical System used for?
The Cryocare Surgical System is designed for use in general and plastic surgery procedures, utilizing cryogenic technology to perform surgical treatments by freezing targeted tissues.
Is the Cryocare Surgical System reusable or single-use?
The Cryocare Surgical System is supplied as a reusable device, meaning it can be used multiple times following appropriate cleaning and reprocessing procedures.
Is the Cryocare Surgical System MRI compatible?
The Cryocare Surgical System is not MRI compatible, so it should not be used in or near magnetic resonance imaging environments.
What regulatory authorization does the Cryocare Surgical System have?
The Cryocare Surgical System is authorized under FDA 510K clearance with product code GEH, indicating it was found substantially equivalent to a legally marketed predicate device.
Who manufactures the Cryocare Surgical System and where is it made?
The Cryocare Surgical System is manufactured by Endocare, Inc. in Irvine, California, United States.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003811 | Class II | Active |
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Manufacturer
- Manufacturer
- Endocare, Inc.
Sources (1)
- FDA 510(k) K003811 24 fields · synced Sep 23, 2026