Cleared Traditional

SafePort(TM) Manifold (or Stopcock)

K211204 · Elcam Medical Acal · General Hospital
Sep 2022
Decision
511d
Days
Class 2
Risk

About This 510(k) Submission

K211204 is an FDA 510(k) clearance for the SafePort(TM) Manifold (or Stopcock), a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Elcam Medical Acal (Baram, IL). The FDA issued a Cleared decision on September 15, 2022, 511 days after receiving the submission on April 22, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K211204 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2021
Decision Date September 15, 2022
Days to Decision 511 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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