MINOP Disposable Introducer 26F— 510(k) K142315

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K142315 for MINOP Disposable Introducer 26F, Substantially Equivalent on 2014-11-14. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code GWG
Advisory panel: Neurology
Date received: 2014-08-19
Decision date: 2014-11-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.