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510(k) K012157

CHURCHILL MEDICAL SYSTEMS STOPCOCK by Churchill Medical Systems, Inc. — Product Code FMG

K012157 is an FDA 510(k) premarket notification submitted by Churchill Medical Systems, Inc. for the device "CHURCHILL MEDICAL SYSTEMS STOPCOCK". The FDA issued a decision of Substantially Equivalent on September 11, 2001. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Churchill Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2001
Date Received
July 11, 2001
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 Churchill Medical Systems, Inc.

  • K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER (December 21, 2004)
  • K021395 — MODIFICATION TO 30 EXTENSION SET (May 13, 2002)
  • K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR (March 27, 2002)
  • K020544 — WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1 (March 12, 2002)
  • K013950 — VENTED VIAL ACCESS DEVICE (January 10, 2002)
  • K011888 — PRESSURE ACTIVATED CHECK VALVE (September 10, 2001)
  • K011336 — PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK (June 12, 2001)
  • K896333 — CMS IV FILTERS (January 11, 1990)
  • K894954 — .22 & 1.2 MICRON IV FILTERS (November 13, 1989)
  • K884370 — CMS IV EXTENSION SETS (November 7, 1988)

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