PNEUMO DRAIN T.M. RECORDER #PD-800— 510(k) K821160

Name: FDA 510(k) clearance K821160
Creator: U.S. Food and Drug Administration
Published: 1982-05-27

Substantially Equivalent

Sugen Industries, Inc.

FDA 510(k) clearance K821160 for PNEUMO DRAIN T.M. RECORDER #PD-800, Substantially Equivalent on 1982-05-27. Applicant: Sugen Industries, Inc.. Device class: 2.

Clearance details

Applicant: Sugen Industries, Inc.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1982-04-22
Decision date: 1982-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.