PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM— 510(k) K091312

Name: FDA 510(k) clearance K091312
Creator: U.S. Food and Drug Administration
Published: 2009-09-02

Substantially Equivalent

Medtronic Neurosurgery

FDA 510(k) clearance K091312 for PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM, Substantially Equivalent on 2009-09-02. Applicant: Medtronic Neurosurgery. Device class: 2.

Clearance details

Applicant: Medtronic Neurosurgery
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 2009-05-04
Decision date: 2009-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXG

view all

K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more2026-06-23
K251598 — Intellidrop2025-12-10
K250636 — Sophy Mini Monopressure Valve (SM1)2025-11-28
K252514 — EVAC-MRI2025-11-05
K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology2025-08-08

More clearances from Medtronic Neurosurgery

view all

K243676 — Duet External Drainage and Monitoring System (EDMS)2025-03-10
K242034 — Duet External Drainage and Monitoring System (EDMS)2024-10-24
K212641 — StrataMR II Valves and Shunts2021-09-16
K181622 — StrataMR guider tool2018-10-01
K161370 — Durepair Dura Regeneration Matrix2016-11-02

Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.