PTI

Non-Coring (Huber) Needle

Product code

PTI

Device name

Non-Coring (Huber) Needle

Device class

Class 2

21 CFR

21 CFR 880.5570

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

4 (direct download)

510(k) clearances (all years, FDA)

13 (all years; only the last 3 years are listed here)

FDA classification definition

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2025-11-26.

4 summaries are archived here for direct download.