K243676
- 510(k) number
- K243676
- Device name
- Duet External Drainage and Monitoring System (EDMS)
- Applicant
- Medtronic Neurosurgery TX · US
- Product code
- JXG — Shunt, Central Nervous System And Components
- Decision date
- 2025-03-10
- Date received
- 2024-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K243676.pdf
Official FDA record: K243676
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.