Minta Ryan Rf Thermocouple Electrode (ryan-50, 100, 150 And 200), Minta Interme…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Minta EUDAMED
- Device Name
- Single-Use RF Electrode EUDAMEDAdapter Cable EUDAMEDReusable RF Electrode EUDAMED
- Model / Reference
- GABI-50L EUDAMEDRYAN-C EUDAMEDRYAN-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060224330500 EUDAMED05060224331187 EUDAMED05060224330005 EUDAMED
- Basic UDI-DI
- 506022433RFSINGLE02SW EUDAMED506022433RFCABLE03LP EUDAMED506022433RFREUSE016B EUDAMED
- Direct Marketing DI
- 05060224331187 EUDAMED05060224330005 EUDAMED
- 510(k) Number
- K090608 FDA 510(k)
- FDA Product Code
- GXI FDA 510(k)
- EMDN Code
- K02030101 RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE EUDAMEDL181003 ELECTROSURGERY CONNECTION CABLES, REUSABLE EUDAMEDL189001 ELECTROSURGICAL DENERVATION PROBES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4725 FDA 510(k)
- Regulation Number
- 882.4725 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
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
Yes
Incorporates Medicinal Product
No
This device is a Probe, Radiofrequency Lesion, designed for the controlled delivery of radiofrequency (RF) energy to peripheral nerve tissue. It incorporates a temperature-sensing thermocouple to monitor and regulate thermal effects during lesioning procedures, ensuring precise application of heat for targeted tissue modification.
The Minta Ryan RF Thermocouple Electrode consists of a stainless steel shaft, PET hub, silicone-insulated lead, and plug connector, paired with compatible intermediate cables (Ryan-C, -R, -B). Supplied sterile for single-use, it is classified as Class II under FDA regulations and authorized via 510(k) clearance (K090608) and MDR compliance. The device is intended for use in neurosurgical settings, adhering to MRI-safe guidelines for non-ferromagnetic components.
Frequently asked questions
What is the primary purpose of the Minta Ryan RF Thermocouple Electrode in clinical settings?
The Minta Ryan RF Thermocouple Electrode is designed for controlled delivery of radiofrequency (RF) energy to peripheral nerve tissue during neurosurgical procedures. It includes a built-in thermocouple to monitor and regulate temperature, ensuring precise heat application for targeted tissue modification, which helps achieve controlled lesioning.
Are the Minta Ryan RF Thermocouple Electrode and its intermediate cables intended for single-use or reusable applications?
The Minta Ryan RF Thermocouple Electrode is supplied sterile for single-use only, as explicitly stated in the device description. This ensures patient safety and sterility during procedures. The intermediate cables (Ryan-C, -R, -B) are paired with the electrode but their reuse status is not specified in the provided data.
What sizes or models of the Minta Ryan RF Thermocouple Electrode are available, and how do they differ?
The device is available in four models: RYAN-50, RYAN-100, RYAN-150, and RYAN-200, though the exact numerical differences (e.g., shaft length, tip design, or power output) are not detailed in the provided data. These models are likely tailored for varying clinical applications or patient anatomies within neurosurgical procedures.
How should the Minta Ryan RF Thermocouple Electrode be stored to maintain its integrity?
Since the electrode is supplied sterile for single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before use to preserve sterility and functionality. Specific storage conditions (e.g., refrigeration) are not mentioned in the data.
What regulatory pathways does the Minta Ryan RF Thermocouple Electrode follow, and what does this imply for clinicians?
The device is authorized via FDA 510(k) clearance (K090608) and MDR compliance, indicating it has undergone regulatory review for safety and effectiveness. Clinicians can rely on this clearance as evidence of the device’s compliance with U.S. and EU regulatory standards, though they should always refer to the manufacturer’s instructions for proper use and adherence to local guidelines.
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: Minta Ryan Rf Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta ..., Minta Ryan Rf Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta ..., www.accessdata.fda.gov
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 | K090608 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Minta Medical Limited
Sources (4)
- FDA 510(k) K090608 24 fields · synced Sep 18, 2026
- EUDAMED 4e0fe97f-8400-410c-887c-c8520c286a8f 61 fields · synced Jul 11, 2026
- EUDAMED 7c219de8-a40c-4ebc-b5cc-c1168a215203 61 fields · synced Jul 30, 2026
- EUDAMED 34641f41-4d41-45a6-a2f2-544a20eb826a 61 fields · synced Sep 17, 2026