Cleared Traditional

VeriSafe Safety sterile syringes

K231792 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Sep 2023
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K231792 is an FDA 510(k) clearance for the VeriSafe Safety sterile 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 28, 2023, 100 days after receiving the submission on June 20, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K231792 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2023
Decision Date September 28, 2023
Days to Decision 100 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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