← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
JXG — Shunt, Central Nervous System And Components
DEVICE CLASS
Class II
REGULATION
21 CFR 882.5550
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
10
510(K)/PMA CLEARANCES
510k: 10
0
RECALL ENTRIES
Recent clearances
K261004Integra Lifesciences Production Corporation · 510k2026-06-23
K251598Brainspace, Inc. · 510k2025-12-10
K250636Sophysa · 510k2025-11-28
K252514Phasor Health, LLC · 510k2025-11-05
K243531Integra Lifesciences Production Corporation · 510k2025-08-08
K243552Integra Lifesciences Production Corporation · 510k2025-08-06
K242974Sophysa · 510k2025-06-20
K243205Phasor Health, LLC · 510k2025-06-03
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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