Disposable Aspiration Needle Na-200H

• • Terminated Z-1069-2021 FDA Class II ·initiated 4 Jan 2021

  Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

510(k) Number

K023272 ↗

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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