Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD r…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Koelis
Identifiers
- 510(k) Number
- K171040 FDA 510(k)
- FDA Product Code
- ITX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a transducer, ultrasonic, diagnostic (per FDA classification) designed to provide a fixed path for needle insertion during ultrasound-guided interventions. The reusable guides include four specialized ranges—PERINE, NAIL, CON-LEAD, and LIN-LEAD—each tailored for precise procedural alignment in radiology applications.
The reusable guides are intended for use in radiology settings and are supplied as a set of sterile, single-use components (where applicable) or as reusable instruments, depending on the specific range. They are classified under product code ITX and comply with FDA 510(k) clearance (K171040) and EU MDR regulations. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What specific medical procedures are these reusable guides designed to assist with, and how do they improve precision during those procedures?
These reusable guides are designed to provide a fixed path for needle insertion during ultrasound-guided interventions in radiology. Each range—PERINE, NAIL, CON-LEAD, and LIN-LEAD—is tailored to enhance procedural alignment, ensuring more accurate and controlled needle placement. By offering a stable guide, they help reduce human error and improve outcomes for procedures requiring precise needle guidance, such as biopsies, drainages, or injections.
Are the reusable guides themselves sterile, or do they require additional sterile components when used, and how should they be handled?
The reusable guides are not sterile as a complete set, but they are supplied with sterile, single-use components where applicable (e.g., disposable covers or attachments). The manufacturer provides guidelines for storage and handling to maintain sterility and functionality, emphasizing proper cleaning and disinfection protocols for reusable parts to ensure safe reuse across procedures.
What distinguishes the STEADY PRO range from the other reusable guide ranges (PERINE, NAIL, CON-LEAD, LIN-LEAD), and how might a clinician choose between them?
The STEADY PRO range is grouped with the other reusable guides but isn’t explicitly detailed in the provided data. The PERINE, NAIL, CON-LEAD, and LIN-LEAD ranges are each specialized for specific procedural needs (e.g., perineal, nail-related, or vascular access interventions). Clinicians would select based on the type of intervention—for example, the NAIL range for orthopedic or nail-bed procedures, while the CON-LEAD range may be used for vascular access or catheter placements. The choice depends on the anatomical target and procedural requirements.
How are these devices regulated, and what does the FDA 510(k) clearance (K171040) and EU MDR compliance mean for their use in clinical settings?
The devices carry FDA 510(k) clearance (K171040) under product code ITX, indicating they are deemed *substantially equivalent* to a legally marketed predicate device in the U.S. This means they meet FDA safety and effectiveness requirements for diagnostic ultrasound transducers used in radiology. In the EU, they comply with MDR (Medical Device Regulation), ensuring they meet stringent safety, performance, and traceability standards for clinical use. Both clearances validate their design and manufacturing processes for safe, intended use.
Are these guides meant for single-use or repeated use, and if reusable, what maintenance or cleaning steps are required?
The reusable guides themselves (PERINE, NAIL, CON-LEAD, LIN-LEAD, and STEADY PRO ranges) are designed for repeated use after proper cleaning and disinfection. However, some components (like covers or attachments) may be single-use sterile items. The manufacturer specifies storage and handling protocols to maintain sterility and functionality, which likely include autoclaving, chemical sterilization, or dedicated cleaning procedures—details that should be referenced in the included instructions for use to ensure longevity and safety.
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: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and ..., TP & TR Range Guides | KOELIS, Reusable Guides Ranges (PERINE Range, NAIL Range… - FDA.report, Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and ...
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 | K171040 | Class II | Active |
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Manufacturer
- Manufacturer
- Koelis
Sources (2)
- FDA 510(k) K171040 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026