Non-Coring Needle
by Creative Care Systems, Inc. 510(k)
Active
510(k) K841742
Overview
The Non-Coring Needle is a medical device designed to access implanted ports. It functions by preventing the occurrence of dangerous coring, which happens when a piece of barrier material is released during puncture.
This device is supplied by Creative Care Systems, Inc. and has received FDA 510(k) clearance. Users should refer to the manufacturer's instructions for use and verify the specific size required for the depth of the port being accessed.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841742 | Date6 Jul 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Creative Care Systems, Inc.
Questions
What is the primary function of the Non-Coring Needle?
This device is specifically designed to access implanted ports. Its primary purpose is to prevent coring, a process where a small piece of barrier material is released into the body during the puncture of the port septum.
How should a clinician determine the correct needle size to use?
Clinicians must refer to the manufacturer's instructions for use provided by Creative Care Systems, Inc. It is essential to verify the specific needle size required based on the depth of the implanted port being accessed to ensure safe and effective performance.
What is the regulatory status of this device?
The Non-Coring Needle manufactured by Creative Care Systems, Inc. has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.