Puncture needles belong to several types of medical devices

Objective To measure the tips of several Tuohy epidural needles (EN) and discuss their clinical significance. Methods 51 pieces of 18GEN from 6 different manufacturers were processed by computer and measured on the printed image (1) The distance PA from the intersection point A of the EN central axis L and the back of the needle bevel mouth to the needle tip P. (2) The vertical distance PB from P to L. (3) The angle of the longest diameter line PC and PA of the needle bevel. The ease of 25G pen-pointed spinal needle (SN) passing through the EN oblique opening was observed in vitro, and the angle between the penetrating part of the SN and the EN was measured. Results (1) There were significant differences in PA, PB, and among various ENs (P<0.05 or=""><0.01). (2)="" the="" difficulty="" of="" sn="" passing="" through="" various="" ens="" was="" different=""><0.01). (3)="" there="" were="" highly="" significant="" differences="" in="" pa,="" pb,="" β="" and="" α="" among="" different="" levels="" of="" difficulty=""><0.01). conclusion="" the="" shape="" of="" en="" needles="" produced="" by="" different="" manufacturers="" is="">

General puncture needles belong to Class 2 medical devices, but biopsy puncture needles, lumbar puncture needles, disposable sterile puncture needles, etc., all belong to Class 3 medical devices.

You can check the data on the website of the State Food and Drug Administration, click on imported medical devices, and enter the puncture needle. The registration approval number of all imported puncture needles can be inquired.

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