Non-Coring (Huber) Needle

What Is This Device?

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.

How Is PTI Classified?

Non-Coring (Huber) Needle is FDA product code PTI, Class 2, 21 CFR 880.5570.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 4 clearances under this code; the FDA took a median of 113 days from receipt to decision on them. 2 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 12 recalls under this product code since 2020. None was by a company in China. The root cause the FDA records most often is Process control (12).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.