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510(k) K082106

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) by Elcam Medical Acal — Product Code FMG

K082106 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)". The FDA issued a decision of Substantially Equivalent on October 2, 2008. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Elcam Medical Acal has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2008
Date Received
July 25, 2008
Clearance Type
Special
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

  • K231900 — A-TAP (previously called Arthrotap) (July 25, 2023)
  • K211204 — SafePort(TM) Manifold (or Stopcock) (September 15, 2022)
  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)
  • 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)

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)
  • 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)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)

FDA data resources