The Gripper(Tm) Port-a-Cath Needles

• • Terminated Z-0189-2020 FDA Class II ·initiated 8 Jul 2019

  Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

510(k) Number

K870866 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What are THE GRIPPER Port-A-Cath Needles used for?

  These needles are designed to access implantable access systems like PORT-A-CATH, PORT-A-CATH II, ProPort®, and P.A.S. PORT®. They are used to establish vascular access for the infusion or withdrawal of fluids and medications.

• Are THE GRIPPER Port-A-Cath Needles for single use?

  Yes, the device is intended for single use. This is a standard safety and infection control practice for medical devices that penetrate the skin.

• How are THE GRIPPER Port-A-Cath Needles supplied?

  They are supplied as part of implantable port and port access needle trays. These trays may include additional components such as guidewires, dilators, and safety needles.

• What is the regulatory status of THE GRIPPER Port-A-Cath Needles?

  The device is regulated under FDA 510(k) clearance with the number K870866. This indicates it has been cleared for marketing as substantially equivalent to a predicate device.