Cleared Traditional

DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD

K123084 · Elcam Medical Acal · General Hospital
May 2013
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K123084 is an FDA 510(k) clearance for the DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on May 23, 2013, 234 days after receiving the submission on October 1, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K123084 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2012
Decision Date May 23, 2013
Days to Decision 234 days
Submission Type Traditional
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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