Cleared Traditional

K173029 - Nipro Syringe
(FDA 510(k) Clearance)

K173029 · Nipro Medical Corporation · General Hospital

Mar 2018

Decision

183d

Days

Class 2

Risk

K173029 is an FDA 510(k) clearance for the Nipro Syringe. This device is classified as a Syringe, Piston (Class II — Special Controls, product code FMF).

Submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on March 30, 2018, 183 days after receiving the submission on September 28, 2017.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K173029 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2017
Decision Date	March 30, 2018
Days to Decision	183 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF