NELSON-JUNG PLEURAL CATH— 510(k) K854812

Name: FDA 510(k) clearance K854812
Creator: U.S. Food and Drug Administration
Published: 1986-02-11

Substantially Equivalent

Research Medical, Inc.

FDA 510(k) clearance K854812 for NELSON-JUNG PLEURAL CATH, Substantially Equivalent on 1986-02-11. Applicant: Research Medical, Inc.. Device class: 1.

Clearance details

Applicant: Research Medical, Inc.
Product code: Code GBW
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1985-12-03
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GBW

product code GBW

Death: 6
Total: 6

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.