JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K142564 ↗

FDA Product Code

FIE

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Neoshield

  Class II

  FDA 510(k) K172499 Active Cleared 1 Jun 2018

• Sysloc Mini V3

  Class II

  FDA 510(k) K110157 Active Cleared 11 Feb 2011

• Jms Sysloc Mini Avf and Apheresis Needle Sets

  Class II

  FDA 510(k) K070234 Active Cleared 22 May 2007

• Jms Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300

  Class II

  FDA 510(k) K093637 Active Cleared 9 Feb 2010

• JMS Harmony A.V. Fistula Needle Set

  Class II

  FDA 510(k) K151017 Active Cleared 13 May 2015

• Jms Extension Set with Planecta, Planecta (Stand Alone Unit), Planecta Lock & Planecta Adaptor

  Class II

  FDA 510(k) K023668 Active Cleared 1 Jul 2003

See all devices from JMS North America Corporation →

• What is the JMS SysLoc MINI A.V. Fistula Needle Set (V4) used for?

  The device is a needle set intended for fistula and apheresis procedures, as indicated by its device name and classification under 'Needle, Fistula' in the openFDA data. It is designed for use in gastroenterology and urology specialties, supporting vascular access during these treatments.

• How is the JMS SysLoc MINI A.V. Fistula Needle Set (V4) supplied and sterilized?

  The device is supplied by JMS North America Corporation as a sterile, single-use needle set. While the data does not explicitly state the sterilization method, its classification as a Class II device under FDA 510(k) clearance implies it meets sterility requirements for single-use medical devices in vascular access procedures.

• Is the JMS SysLoc MINI A.V. Fistula Needle Set (V4) reusable or single-use?

  The device is intended for single-use only, as is standard for needle sets in fistula and apheresis procedures to prevent cross-contamination and ensure patient safety. Reuse is not indicated or supported by the device's regulatory classification or labeling.

• What sizes or models are available for the JMS SysLoc MINI A.V. Fistula Needle Set (V4)?

  The device is specifically identified as the 'V4' model under the JMS SysLoc MINI A.V. Fistula Needle Set and JMS SysLoc MINI Apheresis Needle Set product lines. No additional sizes or model variations are described in the provided data; the V4 designation distinguishes this specific configuration.

• What regulatory pathway was used for the JMS SysLoc MINI A.V. Fistula Needle Set (V4)?

  The device received FDA 510(k) clearance under submission K142564, demonstrating substantial equivalence to a legally marketed predicate device. This Class II clearance under regulation 876.5540 confirms its regulatory pathway as a special 510(k) submission.