Cleared Traditional

BD Texium? Needle-Free Syringe

K231888 · Care Fusion · General Hospital
Sep 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K231888 is an FDA 510(k) clearance for the BD Texium? Needle-Free Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on September 25, 2023, 90 days after receiving the submission on June 27, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K231888 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2023
Decision Date September 25, 2023
Days to Decision 90 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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