AMT DECOMPRESSION TUBES— 510(k) K980145

Name: FDA 510(k) clearance K980145
Creator: U.S. Food and Drug Administration
Published: 1998-04-10

Substantially Equivalent

Applied Medical Technology, Inc.

FDA 510(k) clearance K980145 for AMT DECOMPRESSION TUBES, Substantially Equivalent on 1998-04-10. Applicant: Applied Medical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Applied Medical Technology, Inc.
Product code: Code KGC
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1998-01-15
Decision date: 1998-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGC

product code KGC

Death: 7
Total: 7

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.