FDA product code JXG: Shunt, Central Nervous System And Components
JXG is the FDA product code for shunt, central nervous system and components. It is a Class II device, regulated under 21 CFR 882.5550 and reviewed by the Neurology panel. FDA has cleared 259 510(k) submissions under JXG, 21 in the last five years, from 60 different applicants. The average 510(k) review took 125 days (median 89); 138 days on average over the last three years. FDA has posted 108 recalls for JXG devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Shunt, Central Nervous System And Components |
| Device class | Class II |
| Regulation | 21 CFR 882.5550 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JXG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 112 |
| 2018 | 6 | 162 |
| 2019 | 4 | 110 |
| 2020 | 2 | 31 |
| 2021 | 1 | 27 |
| 2022 | 4 | 86 |
| 2023 | 5 | 141 |
| 2024 | 3 | 113 |
| 2025 | 8 | 212 |
| 2026 | 1 | 89 |
Compare with all 510(k) review times · Search every JXG clearance
Top JXG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 23 | 2017-10-16 |
| Holter-Hausner Intl. | 21 | 1988-07-14 |
| Medtronic Neurosurgery | 18 | 2025-03-10 |
| Cordis Corp. | 18 | 1996-12-20 |
| Pudenz-Schulte Medical Research Corp. | 18 | 1995-09-18 |
55 more applicants have JXG clearances. See the full list in Caduvo.
Most recent JXG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261004 | Integra Lifesciences Production Corporation | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | 2026-06-23 | 89 |
| K251598 | Brainspace, Inc. | Intellidrop | 2025-12-10 | 197 |
| K250636 | Sophysa | Sophy Mini Monopressure Valve (SM1) | 2025-11-28 | 270 |
| K252514 | Phasor Health, LLC | EVAC-MRI | 2025-11-05 | 86 |
| K243531 | Integra Lifesciences Production Corporation | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | 2025-08-08 | 267 |
Recalls for JXG devices
108 product recalls in 35 recall events; 10 initiated in the last five years and 19 still open. Most recent: 2026-04-10.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2019 | 3 |
| 2020 | 8 |
| 2021 | 4 |
| 2023 | 3 |
| 2024 | 6 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JXG?
JXG is the FDA product code for shunt, central nervous system and components. It is a Class II device, regulated under 21 CFR 882.5550 and reviewed by the Neurology panel.
What device class is JXG?
Class II, regulation 21 CFR 882.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code JXG?
Across 259 cleared submissions the average was 125 days from receipt to decision (median 89).
Which companies have the most JXG clearances?
Codman & Shurtleff, Inc. (23); Holter-Hausner Intl. (21); Medtronic Neurosurgery (18); Cordis Corp. (18); Pudenz-Schulte Medical Research Corp. (18).
Have JXG devices been recalled?
Yes: 108 product recalls across 35 recall events; the most recent began 2026-04-10.
Next steps
- Run an FDA pathway report with predicate devices for product code JXG
- Run a recall and safety report across every JXG manufacturer
- Watch product code JXG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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