Cleared Traditional

TK Sterile Hypodermic Needle

K191643 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
Dec 2019
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K191643 is an FDA 510(k) clearance for the TK Sterile Hypodermic Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on December 19, 2019, 183 days after receiving the submission on June 19, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K191643 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2019
Decision Date December 19, 2019
Days to Decision 183 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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