Reusable Interface Cable 1.5 m (PRD-IFC-002)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242061 FDA 510(k)
- FDA Product Code
- KNS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4300 FDA 510(k)
- Regulation Number
- 876.4300 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a reusable interface cable classified as an Electrosurgical, Endoscopic (With or Without Accessories) unit. It facilitates the transfer of radiofrequency (RF) and microwave energy between compatible Creo Medical surgical instruments and the CROMA Electrosurgical Generator, enabling precise tissue cutting, coagulation, and ablation in gastrointestinal procedures.
The Reusable Interface Cable 1.5 m (PRD-IFC-002) is designed for reusable use in controlled clinical settings, such as operating rooms or endoscopic suites. It is supplied sterile or non-sterile as required by the procedure, with a fixed length of 1.5 meters. Authorised under FDA 510K and MDR, it adheres to regulatory standards for electrosurgical devices, ensuring compatibility with MRI environments where applicable. Storage follows manufacturer guidelines to maintain functionality and sterility.
Frequently asked questions
What is the primary purpose of the Reusable Interface Cable 1.5 m (PRD-IFC-002) in surgical procedures?
The Reusable Interface Cable 1.5 m (PRD-IFC-002) is designed to transfer radiofrequency (RF) and microwave energy between compatible Creo Medical surgical instruments and the CROMA Electrosurgical Generator. This enables precise tissue cutting, coagulation, and ablation during gastrointestinal procedures, ensuring controlled energy delivery for safe and effective surgical outcomes.
Is this device intended for single-use or reusable applications, and where would it typically be used?
This device is explicitly designed for reusable use in controlled clinical settings like operating rooms or endoscopic suites. Its durable construction and regulatory authorization (FDA 510K and MDR) support repeated use under proper maintenance protocols, making it suitable for high-volume procedural environments.
How is the sterility of this cable managed, and can it be supplied in a sterile or non-sterile state?
The Reusable Interface Cable 1.5 m can be supplied either sterile or non-sterile, depending on the procedural requirements. Since it is reusable, sterility must be maintained through manufacturer-recommended cleaning, disinfection, and storage protocols to ensure safe reuse in clinical settings.
What length is this cable, and are there variations in sizing or models available?
This specific model, the PRD-IFC-002, has a fixed length of 1.5 meters. While the data does not list alternative lengths or models, the device is categorized under the product code KNS (Electrosurgical, Endoscopic), suggesting compatibility with a range of endoscopic procedures. For exact sizing options, consult Creo Medical’s product catalog or technical specifications.
What regulatory pathways does this device follow, and how does that affect its use in MRI environments?
The device is authorized under FDA 510K and MDR (Medical Device Regulation), confirming compliance with electrosurgical safety standards. While the data does not specify MRI compatibility explicitly, the mention of adherence to MRI environments in the description implies it has been designed to minimize interference risks when used in such settings. Always verify compatibility with your specific MRI system and follow manufacturer 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: CREO MEDICAL LIMITED PRD-IFC-002 Reusable Interface Cable, 1.5 m, Reusable Interface Cable, 1.5 m PRD-IFC-002 The… - FDA.report, AccessGUDID - DEVICE: Reusable Interface Cable, 1.5 m (05060359560834)
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 | K242061 | Class II | Active |
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Manufacturer
- Manufacturer
- Creo Medical, Ltd.
Sources (2)
- FDA 510(k) K242061 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026