TU SUCTIONTRAP— 510(k) K884944

Name: FDA 510(k) clearance K884944
Creator: U.S. Food and Drug Administration
Published: 1989-02-03

Substantially Equivalent

Tulan Corp. C/O Richard Hamer Assoc.

FDA 510(k) clearance K884944 for TU SUCTIONTRAP, Substantially Equivalent on 1989-02-03. Applicant: Tulan Corp. C/O Richard Hamer Assoc.. Device class: 1.

Clearance details

Applicant: Tulan Corp. C/O Richard Hamer Assoc.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1988-11-25
Decision date: 1989-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

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K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

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K881805 — TU STOPCOCK1988-10-04

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.