Cleared Traditional

Verifine Safety Syringe with Fixed Needle

K213560 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Apr 2022
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K213560 is an FDA 510(k) clearance for the Verifine Safety Syringe with Fixed Needle, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on April 5, 2022, 147 days after receiving the submission on November 9, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K213560 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2021
Decision Date April 05, 2022
Days to Decision 147 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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