Cleared Traditional

Verifine Mechanical Safety Insulin Syringe

K210712 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Sep 2021
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K210712 is an FDA 510(k) clearance for the Verifine Mechanical Safety Insulin Syringe, 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 September 8, 2021, 182 days after receiving the submission on March 10, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K210712 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2021
Decision Date September 08, 2021
Days to Decision 182 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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