TERUFUSION THREE-WAY STOPCOCK— 510(k) K823469

Name: FDA 510(k) clearance K823469
Creator: U.S. Food and Drug Administration
Published: 1982-12-30

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K823469 for TERUFUSION THREE-WAY STOPCOCK, Substantially Equivalent on 1982-12-30. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1982-11-22
Decision date: 1982-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, 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 Terumo Medical Corp.

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K111606 — PINNACLE PRECISION ACCESS SYSTEM2011-10-03
K111556 — GLIDECROSS SUPPORT CATHETER2011-07-29
K110540 — TERUMO SUPPORT CATHETER2011-05-13
K102008 — GLIDESHEATH2010-07-21
K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2009-05-29

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.