Cleared Traditional

TK Sterile Piston Syringe without Needle

K191642 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
Jan 2020
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K191642 is an FDA 510(k) clearance for the TK Sterile Piston Syringe without Needle, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on January 6, 2020, 201 days after receiving the submission on June 19, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K191642 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2019
Decision Date January 06, 2020
Days to Decision 201 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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