Cleared Traditional

Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes

K211242 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Sep 2021
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K211242 is an FDA 510(k) clearance for the Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes, 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 9, 2021, 136 days after receiving the submission on April 26, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K211242 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2021
Decision Date September 09, 2021
Days to Decision 136 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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