Medtronic Surgical Navigation Technologies: FDA clearances and approvals
Medtronic Surgical Navigation Technologies has 12 FDA 510(k) clearances (first 2000, latest 2005), across 2 product codes in 2 review panels. Median 510(k) review time: 60 days. openFDA lists 1 product recall by a recalling firm named Medtronic Surgical Navigation Technologies.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 11 | 11 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
Review panels
- Neurology (11)
- Cardiovascular (1)
Most recent Medtronic Surgical Navigation Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050438 | STEALTHSTATION SYSTEM UPDATE | HAW | 2005-06-02 | 100 |
| K043088 | MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE | HAW | 2005-01-05 | 58 |
| K030552 | IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM | HAW | 2003-03-19 | 26 |
| K030106 | STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE | HAW | 2003-02-12 | 30 |
| K022126 | CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM | HAW | 2003-01-03 | 186 |
| K021980 | HIP MODULE FOR THE STEALTHSTATION SYSTEM | HAW | 2002-11-19 | 155 |
| K022414 | STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE | HAW | 2002-08-14 | 21 |
| K020338 | STEALTHSTATION WITH FLUOROMERGE SOFTWARE | HAW | 2002-02-27 | 26 |
| K012937 | KNEE MODULE FOR THE STEALTHSTATION SYSTEM | HAW | 2002-01-25 | 147 |
| K002869 | LOCALISA CARDIAC NAVIGATION SYSTEM | DQK | 2001-03-27 | 195 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-01-28.
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 Surgical Navigation Technologies have?
Medtronic Surgical Navigation Technologies has 12 FDA 510(k) clearances (first 2000, latest 2005), across 2 product codes in 2 review panels.
How long does FDA take to clear Medtronic Surgical Navigation Technologies's 510(k)s?
The median time from FDA receipt to decision across Medtronic Surgical Navigation Technologies's cleared 510(k)s is 60 days.
What devices does Medtronic Surgical Navigation Technologies make?
Its most frequent FDA product codes are HAW (Neurological Stereotaxic Instrument, 11); DQK (Computer, Diagnostic, Programmable, 1).
Has Medtronic Surgical Navigation Technologies had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Medtronic Surgical Navigation Technologies; the most recent began 2005-01-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 Medtronic Surgical Navigation Technologies clearances with predicates and recalls
- Run predicate analysis for product code HAW, Medtronic Surgical Navigation Technologies'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.