SWIVEL COUPLER— 510(k) K863205

Name: FDA 510(k) clearance K863205
Creator: U.S. Food and Drug Administration
Published: 1986-10-02

Substantially Equivalent

Venmill Swivel, Co.

FDA 510(k) clearance K863205 for SWIVEL COUPLER, Substantially Equivalent on 1986-10-02. Applicant: Venmill Swivel, Co.. Device class: 2.

Clearance details

Applicant: Venmill Swivel, Co.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 1986-08-19
Decision date: 1986-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Methuen, MA, US

Download summary PDF View on FDA.gov ↗

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K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-32010-08-20
K081779 — GOLOX-932008-09-19

Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.