Cleared Traditional

Disposable Sterile Needle

K172938 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Jun 2018
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K172938 is an FDA 510(k) clearance for the Disposable Sterile Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on June 14, 2018, 261 days after receiving the submission on September 26, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K172938 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2017
Decision Date June 14, 2018
Days to Decision 261 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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