Coaxial Needle

• • Terminated Z-0289-2017 FDA Class II ·initiated 18 May 2016 ·via K971842, on the same 510(k)

  US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K971842 ↗

FDA Product Code

FCG

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from United States Endoscopy Group, Inc. →