CHURCHILL 3-WAY STOPCOCK— 510(k) K864440

Name: FDA 510(k) clearance K864440
Creator: U.S. Food and Drug Administration
Published: 1987-01-20

Substantially Equivalent

Churchill Corp.

FDA 510(k) clearance K864440 for CHURCHILL 3-WAY STOPCOCK, Substantially Equivalent on 1987-01-20. Applicant: Churchill Corp.. Device class: 2.

Clearance details

Applicant: Churchill Corp.
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1986-11-12
Decision date: 1987-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMG

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K242255 — Qitexio® 4-Way Stopcock (QIT014)2025-04-29
K223499 — Three Way Stop Cock2023-07-21
K223175 — lntravascular Administration Sets with Stopcock and Manifold2023-03-10
K211204 — SafePort(TM) Manifold (or Stopcock)2022-09-15
K210516 — Clicky Cross2022-05-16

More clearances from Churchill Corp.

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K880025 — CHURCHILL 0.22 MICRON LIQUID FILTER SETS1988-04-14
K880026 — CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS1988-04-14
K880051 — ENTERAL BAG/SET1988-04-14
K880027 — CHURCHILL 1.2 MICRON LIQUID FILTER SET1988-04-13
K870395 — CHURCHILL PARENTERAL NUTRITION BAG - EVA1987-10-15

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.