Cleared Traditional

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle

K222852 · Nipro Medical Corporation · General Hospital

May 2023

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K222852 is an FDA 510(k) clearance for the Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on May 25, 2023, 246 days after receiving the submission on September 21, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K222852 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2022
Decision Date	May 25, 2023
Days to Decision	246 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF