Cleared Traditional

K955782 - MED-NET STOPCOCKS (FDA 510(k) Clearance)

Feb 1996
Decision
62d
Days
Class 2
Risk

K955782 is an FDA 510(k) clearance for the MED-NET STOPCOCKS. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).

Submitted by Mednet, Inc. (Sunland, US). The FDA issued a Cleared decision on February 21, 1996, 62 days after receiving the submission on December 21, 1995.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K955782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1995
Decision Date February 21, 1996
Days to Decision 62 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

Similar Devices — FMG Stopcock, I.v. Set

All 88
Qitexio® 4-Way Stopcock (QIT014)
K242255 · Medex · Apr 2025
Three Way Stop Cock
K223499 · M/S Romsons International · Jul 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175 · Baxter Healthcare Corporation · Mar 2023
SafePort(TM) Manifold (or Stopcock)
K211204 · Elcam Medical Acal · Sep 2022
Clicky Cross
K210516 · Yomura Technologies, Inc. · May 2022
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
K190539 · Monumedical, LLC · Oct 2019