Identifiers
- 510(k) Number
- K823068 FDA 510(k)
- FDA Product Code
- KOC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medisystems Fistula Needles are Accessories, Blood Circuit, Hemodialysis (per FDA classification), designed for vascular access in arteriovenous fistulas. These sterile, single-use, hollow-bore needles facilitate efficient blood withdrawal and return during hemodialysis procedures, ensuring reliable hemodialysis access.
Supplied in single-pack configurations (e.g., 250 needles per carton), these needles are intended for use in clinical settings such as dialysis centers. They are classified as Class II devices under FDA regulations (876.5820) and have received FDA 510(k) clearance (K823068) as substantially equivalent to predicate devices. Needles are packaged sterile and must be discarded after a single use to prevent contamination.
Frequently asked questions
What clinical setting are these fistula needles designed for, and how are they typically supplied?
The Medisystems Fistula Needles are specifically designed for use in clinical dialysis centers to facilitate vascular access in arteriovenous fistulas during hemodialysis procedures. They are supplied in single-pack configurations, with each carton containing 250 needles, ensuring sterile and ready-to-use access for routine hemodialysis sessions.
Are these needles reusable, and if not, why must they be discarded after a single use?
No, these needles are intended for single-use only. The manufacturer explicitly states they must be discarded after one use to prevent contamination, ensuring patient safety and maintaining sterile conditions during hemodialysis.
What regulatory pathway was followed for FDA clearance, and what does this mean for healthcare providers?
The Medisystems Fistula Needles received FDA 510(k) clearance (K823068) through a traditional review process, demonstrating they are substantially equivalent to predicate devices. This clearance confirms the device meets FDA safety and effectiveness standards for use as an accessory in blood circuits for hemodialysis, providing healthcare providers with confidence in their regulatory compliance.
How are the needles packaged, and what should clinicians ensure before use?
The needles are packaged sterile in single-pack configurations, ensuring each unit is ready for immediate use. Clinicians should verify the sterility seal is intact before opening and confirm the needle is from a new, unopened pack to maintain aseptic conditions during hemodialysis access.
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 Needles - Medisystems | FDA Reference, Medisystems Fistula Needle - 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 | K823068 | Class II | Active |
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Manufacturer
- Manufacturer
- Medisystems Corp.
Sources (1)
- FDA 510(k) K823068 24 fields · synced Sep 19, 2026