Duet External Drainage and Monitoring System (EDMS)— 510(k) K242034

Name: FDA 510(k) clearance K242034
Creator: U.S. Food and Drug Administration
Published: 2024-10-24

Substantially Equivalent

Medtronic Neurosurgery

FDA 510(k) clearance K242034 for Duet External Drainage and Monitoring System (EDMS), Substantially Equivalent on 2024-10-24. Applicant: Medtronic Neurosurgery. Device class: 2.

Clearance details

Applicant: Medtronic Neurosurgery
Product code: Code PCB
Device class: Class 2
Regulation: 21 CFR 882.5560
Advisory panel: Neurology
Date received: 2024-07-11
Decision date: 2024-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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DEN120017 — Medtronic DUET External Drainage and Monitoring System2014-08-22

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Adverse events under product code PCB

product code PCB

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.