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510(k) K123084

DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD by Elcam Medical Acal — Product Code FMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2013
Date Received
October 1, 2012
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 Elcam Medical Acal

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  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) (July 16, 2012)
  • K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (June 8, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K111016 — SAFEPORT MANIFOLD (TM) (OR STOPCOCK) (June 9, 2011)
  • K100425 — HASKAL TORQUE DEVICE (June 17, 2010)
  • K082106 — ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) (October 2, 2008)

Other clearances for product code FMG

  • K242255 — Qitexio® 4-Way Stopcock (QIT014) (April 29, 2025)
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  • K223175 — lntravascular Administration Sets with Stopcock and Manifold (March 10, 2023)
  • K211204 — SafePort(TM) Manifold (or Stopcock) (September 15, 2022)
  • K210516 — Clicky Cross (May 16, 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)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)