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510(k) K862492

EXEL THREE-WAY STOPCOCK by Exel Intl. — Product Code FMG

K862492 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL THREE-WAY STOPCOCK". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Exel Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
July 1, 1986
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 Exel Intl.

  • K992290 — EXEL INJECTION PLUG WITH CAP (February 23, 2000)
  • K963658 — EXEL AVF SINGLE NEEDLE (May 5, 1998)
  • K963659 — EXEL I.V. ADMINISTRATION SET (December 16, 1997)
  • K926119 — EXEL HUBER INFUSION SET ROTATING WING (August 11, 1993)
  • K904685 — EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) (November 21, 1990)
  • K903945 — EXEL A-V FISTULA SET (November 20, 1990)
  • K895770 — EXEL HUBER INFUSION SET (July 19, 1990)
  • K895771 — EXEL SPINAL NEEDLES (February 16, 1990)
  • K895768 — EXEL SAFELET CATHETER (February 16, 1990)
  • K895772 — EXEL INDWELLING CATHETER (February 16, 1990)

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