Medtronic Neurosurgery: FDA clearances and approvals
Medtronic Neurosurgery has 27 FDA 510(k) clearances (first 2001, latest 2025), plus 1 De Novo decision, across 7 product codes in 3 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 103 days, against 105 days for all cleared 510(k)s in the same product codes. openFDA lists 68 product recalls by a recalling firm named Medtronic Neurosurgery.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 90 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 184 |
| 2017 | 0 | — |
| 2018 | 1 | 103 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 27 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 105 |
| 2025 | 1 | 103 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medtronic Neurosurgery's cleared 510(k)s took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 18 | 18 |
| GXQ | Dura Substitute | 4 | 4 |
| PCB | External Cerebrospinal Fluid (Csf) Diversion | 2 | 1 |
| FZP | Clip, Implantable | 1 | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 | 1 |
| HBO | Clip, Scalp | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Neurology (26)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Medtronic Neurosurgery 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243676 | Duet External Drainage and Monitoring System (EDMS) | JXG | 2025-03-10 | 103 |
| K242034 | Duet External Drainage and Monitoring System (EDMS) | PCB | 2024-10-24 | 105 |
| K212641 | StrataMR II Valves and Shunts | JXG | 2021-09-16 | 27 |
| K181622 | StrataMR guider tool | JXG | 2018-10-01 | 103 |
| K161370 | Durepair Dura Regeneration Matrix | GXQ | 2016-11-02 | 169 |
| K152700 | StrataMR Valves and Shunts | JXG | 2016-04-07 | 199 |
| K123524 | MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | JXG | 2013-02-13 | 90 |
| K110560 | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER | JXG | 2011-11-18 | 263 |
| K091312 | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | JXG | 2009-09-02 | 121 |
| K083076 | STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 | JXG | 2008-11-20 | 35 |
17 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN120017 | De Novo | External Cerebrospinal Fluid (Csf) Diversion | 2014-08-22 |
Recalls
68 product recalls in 20 recall events; 10 initiated in the last five years. Most recent: 2026-06-17.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medtronic Neurosurgery have?
Medtronic Neurosurgery has 27 FDA 510(k) clearances (first 2001, latest 2025), plus 1 De Novo decision, across 7 product codes in 3 review panels.
How long does FDA take to clear Medtronic Neurosurgery's 510(k)s?
The median time from FDA receipt to decision across Medtronic Neurosurgery's cleared 510(k)s is 90 days. Since 2017: 103 days, versus 105 days for all cleared 510(k)s in the same product codes.
What devices does Medtronic Neurosurgery make?
Its most frequent FDA product codes are JXG (Shunt, Central Nervous System And Components, 18); GXQ (Dura Substitute, 4); PCB (External Cerebrospinal Fluid (Csf) Diversion, 2).
Has Medtronic Neurosurgery had device recalls?
openFDA lists 68 product recalls in 20 recall events by a recalling firm whose name matches Medtronic Neurosurgery; the most recent began 2026-06-17. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 27 Medtronic Neurosurgery clearances with predicates and recalls
- Run predicate analysis for product code JXG, Medtronic Neurosurgery's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.