Stryker Instruments, Instruments Div.: FDA clearances and approvals
Stryker Instruments, Instruments Div. has 6 FDA 510(k) clearances (first 2007, latest 2013), across 4 product codes in 4 review panels. Median 510(k) review time: 90 days. openFDA lists 5 product recalls by a recalling firm named Stryker Instruments, Instruments Div.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 44 |
| 2013 | 1 | 170 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 2 | 2 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| GXI | Probe, Radiofrequency Lesion | 1 | 1 |
Review panels
- General Hospital (2)
- Orthopedic (2)
- Anesthesiology (1)
- Neurology (1)
Most recent Stryker Instruments, Instruments Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123178 | STRYKER VENOM ELECTRODES AND CANNULAE | GXI | 2013-03-28 | 170 |
| K113477 | IVAS 20MM (10 GAUGE) BALLOON CATHETER | NDN | 2012-01-06 | 44 |
| K093419 | IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS | NDN | 2010-03-18 | 136 |
| K072702 | STRYKER ANTIMIC CATHETER | BSO | 2008-03-19 | 177 |
| K073017 | STRYKER STRI-SHIELD FLYTE TOGAS | FYA | 2007-11-30 | 36 |
| K070078 | STRYKER T4 HYTREL TOGA | FYA | 2007-02-02 | 24 |
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2004-07-14.
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 Stryker Instruments, Instruments Div. have?
Stryker Instruments, Instruments Div. has 6 FDA 510(k) clearances (first 2007, latest 2013), across 4 product codes in 4 review panels.
How long does FDA take to clear Stryker Instruments, Instruments Div.'s 510(k)s?
The median time from FDA receipt to decision across Stryker Instruments, Instruments Div.'s cleared 510(k)s is 90 days.
What devices does Stryker Instruments, Instruments Div. make?
Its most frequent FDA product codes are FYA (Gown, Surgical, 2); NDN (Cement, Bone, Vertebroplasty, 2); BSO (Catheter, Conduction, Anesthetic, 1).
Has Stryker Instruments, Instruments Div. had device recalls?
openFDA lists 5 product recalls in 4 recall events by a recalling firm whose name matches Stryker Instruments, Instruments Div; the most recent began 2004-07-14. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Stryker Instruments, Instruments Div. clearances with predicates and recalls
- Run predicate analysis for product code FYA, Stryker Instruments, Instruments Div.'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.