Stryker Neurovascular: FDA clearances and approvals
Stryker Neurovascular has 33 FDA 510(k) clearances (first 2011, latest 2026), plus 2 PMA decisions, across 9 product codes in 2 review panels. Median 510(k) review time: 103 days. Since 2017 its median was 118 days, against 116 days for all cleared 510(k)s in the same product codes. openFDA lists 109 product recalls by a recalling firm named Stryker Neurovascular. It is the industry lead sponsor of 20 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 29 |
| 2013 | 2 | 118 |
| 2014 | 1 | 63 |
| 2015 | 0 | — |
| 2016 | 3 | 31 |
| 2017 | 1 | 249 |
| 2018 | 0 | — |
| 2019 | 4 | 54 |
| 2020 | 3 | 30 |
| 2021 | 4 | 186 |
| 2022 | 1 | 114 |
| 2023 | 1 | 153 |
| 2024 | 2 | 188 |
| 2025 | 4 | 115 |
| 2026 | 2 | 84 |
Review time against the same product codes
Since 2017, Stryker Neurovascular's cleared 510(k)s took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 11 | 11 |
| QJP | Catheter, Percutaneous, Neurovasculature | 9 | 9 |
| DQY | Catheter, Percutaneous | 6 | 6 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | 3 | 3 |
| NRY | Catheter, Thrombus Retriever | 2 | 2 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 | 1 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 1 | 1 |
| OUT | Intracranial Aneurysm Flow Diverter | 1 | 0 |
| QCA | Intracranial Coil-Assist Stent | 1 | 0 |
Review panels
- Neurology (28)
- Cardiovascular (7)
Most recent Stryker Neurovascular 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261889 | Trevo Trak 21 Microcatheter | QJP | 2026-07-01 | 26 |
| K253032 | AXS Lift Intracranial Base Catheter | QJP | 2026-02-11 | 142 |
| K252694 | Target Detachable Coil | HCG | 2025-12-11 | 107 |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | HCG | 2025-10-17 | 123 |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | QJP | 2025-03-21 | 231 |
| K243593 | AXS Lift Intracranial Base Catheter | QJP | 2025-02-18 | 90 |
| K241768 | Broadway 8 Catheter | QJP | 2024-12-19 | 182 |
| K241637 | Echo Intracranial Base Catheter | QJP | 2024-12-19 | 195 |
| K223305 | Trevo NXT ProVue Retriever | POL | 2023-03-29 | 153 |
| K222533 | Target Tetra Detachable Coils | HCG | 2022-12-14 | 114 |
23 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180031 | PMA | Neuroform Atlas® Stent System | 2019-05-16 |
| P170024 | PMA | Surpass Streamline Flow Diverter | 2018-07-13 |
Recalls
109 product recalls in 23 recall events; 15 initiated in the last five years. Most recent: 2026-04-06.
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.
Device clinical trials
Stryker Neurovascular is the industry lead sponsor of 20 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT06872684: Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD) (Recruiting, started 2025-06-20)
- NCT06368622: Evolve China PMCF Study (Active not recruiting, started 2024-04-24)
- NCT04572230: International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach (Active not recruiting, started 2020-12-21)
- NCT04380350: Trenza Embolization Device for Intrasaccular Aneurysm Treatment (Active not recruiting, started 2020-12-17)
- NCT04195568: Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System (Active not recruiting, started 2020-07-07)
Frequently asked questions
How many FDA 510(k) clearances does Stryker Neurovascular have?
Stryker Neurovascular has 33 FDA 510(k) clearances (first 2011, latest 2026), plus 2 PMA decisions, across 9 product codes in 2 review panels.
How long does FDA take to clear Stryker Neurovascular's 510(k)s?
The median time from FDA receipt to decision across Stryker Neurovascular's cleared 510(k)s is 103 days. Since 2017: 118 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does Stryker Neurovascular make?
Its most frequent FDA product codes are HCG (Device, Neurovascular Embolization, 11); QJP (Catheter, Percutaneous, Neurovasculature, 9); DQY (Catheter, Percutaneous, 6).
Has Stryker Neurovascular had device recalls?
openFDA lists 109 product recalls in 23 recall events by a recalling firm whose name matches Stryker Neurovascular; the most recent began 2026-04-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 33 Stryker Neurovascular clearances with predicates and recalls
- Run predicate analysis for product code HCG, Stryker Neurovascular'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.