Nipro Coreless Needle/Coreless Needle Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K971582 FDA 510(k)
- FDA Product Code
- LJT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5965 FDA 510(k)
- Regulation Number
- 880.5965 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nipro Coreless Needle/Needle Set is a medical device designed to prevent needle coring during access to implanted reservoirs. It falls under the category of port and catheter devices, intended for subcutaneous, intravascular, or implanted use. The device is constructed with a stainless steel cannula and a luer hub, ensuring secure and reliable injection of drug solutions into implanted reservoirs without the risk of core separation.
This single-use device is supplied sterile and is intended for use in general hospital settings. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The set includes a stainless steel cannula and a protective sheath, typically made of soft PVC, and is designed for one-time use only. Storage should follow manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the Nipro Coreless Needle/Needle Set designed for?
The Nipro Coreless Needle/Needle Set is specifically designed to prevent needle coring during access to implanted reservoirs. This ensures secure and reliable injection of drug solutions without the risk of core separation, making it ideal for subcutaneous, intravascular, or implanted use in hospital settings.
How is the Nipro Coreless Needle/Needle Set supplied?
The device is supplied sterile and as a single-use item. Each set includes a stainless steel cannula and a protective sheath, typically made of soft PVC, ensuring sterility and functionality for one-time use only.
Is the Nipro Coreless Needle/Needle Set reusable?
No, the Nipro Coreless Needle/Needle Set is intended for single-use only. This design ensures patient safety and sterility, as reuse could compromise the integrity of the device and introduce infection risks.
What materials are used in the construction of the Nipro Coreless Needle/Needle Set?
The Nipro Coreless Needle/Needle Set features a stainless steel cannula for durability and reliability, paired with a luer hub for secure connection. The protective sheath is typically made of soft PVC, providing ease of use while maintaining sterility.
How should the Nipro Coreless Needle/Needle Set be stored?
Storage should follow the manufacturer’s guidelines to maintain sterility and functionality. This typically involves keeping the device in its original packaging, away from direct sunlight, extreme temperatures, and contamination until ready for 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. Sources consulted: NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET (K971582) — FDA 510 (k ..., Nipro – Wikipedia, Instructions for Use (IFUs) | Nipro
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971582 | Class II | Active |
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Manufacturer
- Manufacturer
- Nipro Medical Corp.
Sources (1)
- FDA 510(k) K971582 24 fields · synced Oct 1, 2026