Needle, Conduction, Anesthetic (W/Wo Introducer)

How Is BSP Classified?

Needle, Conduction, Anesthetic (W/Wo Introducer) is FDA product code BSP, Class 2, 21 CFR 868.5150.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 3 clearances under this code; the FDA took a median of 239 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 17 recalls under this product code since 2004. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Labeling design (3), Process control (3) and Employee error (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.