Cleared Traditional

Insulin Syringe

K223453 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Mar 2023
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K223453 is an FDA 510(k) clearance for the 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 March 2, 2023, 106 days after receiving the submission on November 16, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K223453 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2022
Decision Date March 02, 2023
Days to Decision 106 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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