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JMS Apheresis Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K880726

by Jms Co., Ltd.

Identifiers

510(k) Number
K880726 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)

This device is a needle intended for use in apheresis procedures to provide access to a patient's blood. It is classified as a fistula needle under FDA device classification and is associated with the medical specialties of gastroenterology and urology.

The JMS Apheresis Needle is supplied as a single-use device and has received FDA 510(k) clearance under product code FIE and regulation number 876.5540. It is manufactured by JMS Co., Ltd. and is intended for use in clinical settings requiring vascular access for apheresis therapy.

Frequently asked questions

What is the JMS Apheresis Needle used for?

The JMS Apheresis Needle is intended for use in apheresis procedures to provide access to a patient's blood, specifically as a fistula needle for vascular access in clinical settings requiring apheresis therapy.

Is the JMS Apheresis Needle supplied sterile and for single-use only?

Yes, the JMS Apheresis Needle is supplied as a single-use device, meaning it is intended for one-time use only and should be discarded after each procedure to prevent cross-contamination and ensure patient safety.

What regulatory clearance does the JMS Apheresis Needle have?

The JMS Apheresis Needle has received FDA 510(k) clearance under product code FIE and regulation number 876.5540, with a traditional clearance type and substantially equivalent decision, as documented in its authorization record.

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: JMS APHERESIS NEEDLE (K974902) — FDA 510(k) | Innolitics, JMS APHERESIS NEEDLE (K990510) — FDA 510(k) | Innolitics, JMS APHERESIS NEEDLE by JMS CO., LTD. | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Jms Co., Ltd.

Sources (1)

  • FDA 510(k) K880726 24 fields · synced Oct 1, 2026