Urethral Warming Catheter Kit
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Urethral Warming Catheter Kit EUDAMEDFDA UDI
- Generic Name
- Cryosurgical set FDA UDI
- Device Name
- Urethral Warming Catheter Kit EUDAMEDUrethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems FDA UDI
- Model / Reference
- DP40-0141-106 EUDAMEDFDA UDI
- Description
- Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems FDA UDI
Identifiers
- Catalog Number
- CRYO-77 FDA UDI
- Primary DI / UDI-DI
- 00810563020977 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200140PL EUDAMED
- 510(k) Number
- FDA Product Code
- GEH FDA 510(k)FDA UDI
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
- GMDN Term
- Cryosurgical set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4350 FDA 510(k)
- Regulation Number
- 878.4350 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The Urethral Warming Catheter Kit is a medical device designed for warming and maintaining the temperature of the urethra during cryosurgical procedures. It consists of a catheter system intended to prevent ice formation and reduce thermal trauma by delivering controlled warmth to the urethral tissue.
The kit is supplied as a single-use, non-sterile assembly and is intended for use in cryosurgical settings, such as prostate cryoablation. It includes components compatible with MRI environments, as indicated by its regulatory classification. The device is authorized under FDA 510(k) clearance and EU MDR, adhering to strict medical device regulations for safety and performance.
Frequently asked questions
What is the primary purpose of the Urethral Warming Catheter Kit during cryosurgical procedures?
The Urethral Warming Catheter Kit is designed to warm and maintain the temperature of the urethra during cryosurgical procedures, such as prostate cryoablation. Its purpose is to prevent ice formation and reduce thermal trauma by delivering controlled warmth to the urethral tissue, ensuring patient safety and procedural effectiveness.
Is the Urethral Warming Catheter Kit intended for single-use or reusable applications?
The Urethral Warming Catheter Kit is explicitly supplied as a single-use device. This design ensures patient safety by eliminating the risk of cross-contamination between procedures, which is critical in sterile medical environments like cryosurgery.
How is the kit supplied, and is it sterile?
The kit is supplied as a non-sterile assembly, meaning it requires additional sterilization or preparation before use. Since it is intended for cryosurgical settings, clinicians must follow proper sterilization protocols to ensure safety during urethral warming procedures.
Can this device be used in MRI environments, and why does that matter?
Yes, the Urethral Warming Catheter Kit includes components compatible with MRI environments, as indicated by its regulatory classification. This is important because cryosurgical procedures often involve MRI guidance for precision, and MRI-safe materials prevent interference or safety hazards during imaging.
What regulatory pathways does the Urethral Warming Catheter Kit follow, and what does that mean for buyers?
The device is authorized under FDA 510(k) clearance and EU MDR (Medical Device Regulation). This means it has undergone rigorous review by regulatory bodies to demonstrate safety and performance, giving buyers confidence in its compliance with U.S. and European medical device standards before clinical use.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211149 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (3)
- FDA 510(k) K211149 24 fields · synced Oct 6, 2026
- FDA UDI e13d44ed-ba25-4597-b7fb-c7e97a5d4b37 35 fields · synced May 30, 2026
- EUDAMED 236675ad-2158-4100-93de-f8d6795183a6 61 fields · synced Aug 2, 2026