Surgical System With Cryoguide
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002615 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)
This device is a cryosurgical unit (Product Code GEH) designed to deliver controlled freezing temperatures to targeted tissues using liquid nitrogen-cooled cryoprobes. It falls under the FDA’s classification for cryosurgical accessories and is intended for use in general and plastic surgery procedures, enabling precise tissue ablation through cryotherapy.
The system includes a console for temperature control and monitoring, along with compatible cryoprobes and temperature probes. It is single-use (as indicated by the associated FEI numbers) and requires sterile handling per FDA 510(k) clearance (K002615). Authorized for use in MRI-compatible environments, it is supplied as a modular kit with specific probe sizes for targeted applications. Regulatory compliance is governed under 21 CFR 878.4350, with no implied or stated approval beyond the documented 510(k) submission.
Frequently asked questions
What types of surgical procedures is this cryosurgical system designed to support, and how does it achieve precision in tissue ablation?
The SURGICAL SYSTEM WITH CRYOGUIDE by Endocare, Inc. is designed for general and plastic surgery procedures, enabling precise tissue ablation through cryotherapy. It delivers controlled freezing temperatures using liquid nitrogen-cooled cryoprobes, allowing targeted treatment with modular probe sizes for specific applications. The system’s console provides real-time temperature control and monitoring, ensuring accuracy during procedures.
Is this device compatible with MRI environments, and how does that affect its use in clinical settings?
Yes, the SURGICAL SYSTEM WITH CRYOGUIDE is explicitly authorized for use in MRI-compatible environments. This compatibility ensures it can be safely integrated into clinical workflows where MRI imaging is required, reducing the need for patient repositioning or additional procedures. The system’s design accounts for MRI safety standards, making it suitable for multi-modal settings.
How is the device supplied, and what should clinicians know about its sterility and single-use nature?
The SURGICAL SYSTEM WITH CRYOGUIDE is supplied as a modular kit, including a console for temperature control and a variety of compatible cryoprobes and temperature probes. It is single-use only, as indicated by the associated FDA Establishment Inspection Report (FEI) numbers. Per the FDA’s 510(k) clearance (K002615), sterile handling is mandatory to ensure patient safety, and each component is intended for one-time use only.
What regulatory pathway was followed for this device’s clearance, and what does that mean for clinicians or purchasers?
The SURGICAL SYSTEM WITH CRYOGUIDE received FDA clearance through a Traditional 510(k) pathway (K002615), determined to be *substantially equivalent* to a legally marketed predicate device. This means the FDA reviewed it against existing cryosurgical accessories (Product Code GEH) and confirmed compliance with 21 CFR 878.4350. Clinicians or purchasers can rely on this clearance as evidence of regulatory scrutiny for safety and performance in cryotherapy applications, though they should always verify the specific FEI numbers for single-use components.
Are there multiple probe sizes available, and how do clinicians select the appropriate one for a procedure?
Yes, the system includes a range of modular cryoprobes with varying sizes, as referenced by the multiple FEI numbers in the regulatory data. Clinicians should select the probe size based on the targeted tissue area and procedure requirements, ensuring compatibility with the console’s temperature control features. The manufacturer’s instructions (not provided here) would detail specific probe applications, but the modular design allows flexibility for general and plastic surgery needs.
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. Sources consulted: Intuitive Surgical – Wikipedia, K002615 FDA 510(k) - SURGICAL SYSTEM WITH CRYOGUIDE, PDF etending life everydayJ) 510(K) SUMMARY Koou, SURGICAL SYSTEM WITH CRYOGUIDE (K002615) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002615 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endocare, Inc.
Sources (1)
- FDA 510(k) K002615 24 fields · synced Sep 19, 2026