Cleared Special

Elcam Stopcocks and Manifolds

K190489 · Elcam Medical Acal · General Hospital
Apr 2019
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K190489 is an FDA 510(k) clearance for the Elcam Stopcocks and Manifolds, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Elcam Medical Acal (-, IL). The FDA issued a Cleared decision on April 23, 2019, 54 days after receiving the submission on February 28, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K190489 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2019
Decision Date April 23, 2019
Days to Decision 54 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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