Home / 510(k) Clearances / K210516

510(k) K210516

Clicky Cross by Yomura Technologies, Inc. — Product Code FMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2022
Date Received
February 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Yomura Technologies, Inc.

  • K112542 — YOMURA SAFETY I.V. CATHETER (February 8, 2012)

Other clearances for product code FMG

  • K242255 — Qitexio® 4-Way Stopcock (QIT014) (April 29, 2025)
  • K223499 — Three Way Stop Cock (July 21, 2023)
  • K223175 — lntravascular Administration Sets with Stopcock and Manifold (March 10, 2023)
  • K211204 — SafePort(TM) Manifold (or Stopcock) (September 15, 2022)
  • K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal (October 22, 2019)
  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)