4-WAY STOPCOCK W/100 CM TUBING, LUER-LK— 510(k) K760678

Name: FDA 510(k) clearance K760678
Creator: U.S. Food and Drug Administration
Published: 1976-12-02

Substantially Equivalent

American Viggo

FDA 510(k) clearance K760678 for 4-WAY STOPCOCK W/100 CM TUBING, LUER-LK, Substantially Equivalent on 1976-12-02. Applicant: American Viggo. Device class: 2.

Clearance details

Applicant: American Viggo
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1976-09-20
Decision date: 1976-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMG

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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 American Viggo

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K771339 — MALE LUER LOCK PLUG1977-08-02
K770528 — NEEDLE, MEMBRANE1977-04-29
K770174 — LUER-LOCK EXTENSION SET1977-03-30
K770181 — I.V. CATHETER PLACEMENT UNIT1977-03-30
K770154 — 3-WAY STOPCOCK WITH LUER-LOCK FITTING1977-02-28

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.