Identifiers
- 510(k) Number
- K811838 FDA 510(k)
- FDA Product Code
- FIE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5540 FDA 510(k)
- Regulation Number
- 876.5540 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medisystems Fistula Needle is a Needle, Fistula (per FDA nomenclature), classified as a Class II medical device. It is a hollow-bore, large-gauge needle specifically designed for accessing arteriovenous fistulas in patients requiring hemodialysis. Its primary function is to establish vascular access for efficient blood flow during dialysis procedures, ensuring reliable and high-volume fluid exchange.
This device is supplied as a single-use, sterile product, intended for use in hemodialysis settings. It is manufactured in multiple gauge sizes and lengths, including 1 inch and 1¼ inch variants, with associated tubing and connectors. The Medisystems Fistula Needle holds FDA 510(k) clearance (K811838) under the Gastroenterology, Urology advisory committee and is regulated under 21 CFR 876.5540. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.
Frequently asked questions
What is the Medisystems Fistula Needle used for?
The Medisystems Fistula Needle is specifically designed to establish vascular access in arteriovenous (AV) fistulas for hemodialysis patients. Its large-gauge, hollow-bore design ensures efficient blood flow and high-volume fluid exchange during dialysis procedures, making it essential for maintaining reliable access in clinical settings.
How is the Medisystems Fistula Needle supplied, and is it reusable?
The Medisystems Fistula Needle is supplied as a single-use, sterile product, meaning each unit is intended for one-time use only. This design minimizes infection risks and ensures patient safety by preventing cross-contamination between patients. Always follow sterile medical device protocols when handling and storing the device.
What sizes and models are available for the Medisystems Fistula Needle?
The Medisystems Fistula Needle comes in multiple configurations, including variations in gauge and length. Common options include 1-inch and 1¼-inch lengths, though the exact specifications may vary by lot or batch. The device is also available with associated tubing and connectors to facilitate seamless integration into dialysis circuits. For precise sizing details, refer to the product packaging or consult the manufacturer’s documentation.
How should the Medisystems Fistula Needle be stored to maintain sterility?
To preserve sterility, the Medisystems Fistula Needle must be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture, chemicals, or physical damage that could compromise the sterile barrier. Always adhere to sterile medical device storage guidelines to ensure the device remains intact and safe for use.
Is the Medisystems Fistula Needle regulated under any specific FDA guidelines?
Yes, the Medisystems Fistula Needle holds FDA 510(k) clearance (K811838) and is regulated under 21 CFR 876.5540. This classification ensures it meets stringent safety and performance standards for use in hemodialysis access. The device is classified as a Class II medical device, indicating it undergoes rigorous review by the FDA’s Gastroenterology and Urology advisory committee.
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: Medisystems Medic Plastic Needles - Medline, Fistula Needles - BBraunUSA.com, Medisystems Fistula Needle - Medisystems | FDA Reference, Medisystems Fistula Needles - Medisystems | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K811838 | Class II | Active |
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Manufacturer
- Manufacturer
- Medisystems Corp.
Sources (1)
- FDA 510(k) K811838 24 fields · synced Oct 1, 2026