Cleared Traditional

Clicky Cross

K210516 · Yomura Technologies, Inc. · General Hospital
May 2022
Decision
447d
Days
Class 2
Risk

About This 510(k) Submission

K210516 is an FDA 510(k) clearance for the Clicky Cross, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Yomura Technologies, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on May 16, 2022, 447 days after receiving the submission on February 23, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K210516 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2021
Decision Date May 16, 2022
Days to Decision 447 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
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
Elcam Stopcocks and Manifolds
K190489 · Elcam Medical Acal · Apr 2019