MADEGOM LTDA. PENROSE DRAIN TUBING— 510(k) K894119

Name: FDA 510(k) clearance K894119
Creator: U.S. Food and Drug Administration
Published: 1989-08-18

Substantially Equivalent

Madegom

FDA 510(k) clearance K894119 for MADEGOM LTDA. PENROSE DRAIN TUBING, Substantially Equivalent on 1989-08-18. Applicant: Madegom. Device class: 1.

Clearance details

Applicant: Madegom
Product code: Code GBW
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1989-06-12
Decision date: 1989-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chile, CL

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.