AMT Suture Delivery System— 510(k) K193612

Name: FDA 510(k) clearance K193612
Creator: U.S. Food and Drug Administration
Published: 2020-03-12

Substantially Equivalent

Applied Medical Technology, Inc.

FDA 510(k) clearance K193612 for AMT Suture Delivery System, Substantially Equivalent on 2020-03-12. 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: 2019-12-26
Decision date: 2020-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brecksville, 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.