Cleared Traditional

Auto Disable Syringe

K210464 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
Aug 2021
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K210464 is an FDA 510(k) clearance for the Auto Disable Syringe, 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 August 24, 2021, 189 days after receiving the submission on February 16, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K210464 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2021
Decision Date August 24, 2021
Days to Decision 189 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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