ASLAN KNOT PUSHER— 510(k) K950924

Name: FDA 510(k) clearance K950924
Creator: U.S. Food and Drug Administration
Published: 1995-03-14

Substantially Equivalent

Aslan Medical Technologies, Ltd.

FDA 510(k) clearance K950924 for ASLAN KNOT PUSHER, Substantially Equivalent on 1995-03-14. Applicant: Aslan Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Aslan Medical Technologies, Ltd.
Product code: Code FDE
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1995-03-01
Decision date: 1995-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDE

product code FDE

Other: 1
Total: 1

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.