Medtronic PS Medical: FDA clearances and approvals
Medtronic PS Medical has 14 FDA 510(k) clearances (first 1996, latest 2002), across 8 product codes in 3 review panels. Median 510(k) review time: 89 days.
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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | 4 | 4 |
| JXG | Shunt, Central Nervous System And Components | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 | 1 |
| GXR | Cover, Burr Hole | 1 | 1 |
| HCA | Catheter, Ventricular | 1 | 1 |
| LIS | 1 | 1 | |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
Review panels
- Neurology (11)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Medtronic PS Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012052 | MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 | JXG | 2002-02-11 | 224 |
| K010361 | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 | GXR | 2001-05-07 | 90 |
| K010487 | BIPOLAR PENCIL, MODEL 3901-002, 3900-002 | GEI | 2001-05-03 | 72 |
| K010341 | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, | GWG | 2001-04-20 | 74 |
| K003914 | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES | GWG | 2001-02-22 | 65 |
| K002572 | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 | GWG | 2000-11-16 | 90 |
| K991502 | MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 | JXG | 2000-09-12 | 502 |
| K990333 | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 | GWG | 1999-04-28 | 84 |
| K984053 | BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM | JXG | 1999-02-04 | 90 |
| K983799 | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL | GWM | 1999-01-26 | 90 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medtronic PS Medical.
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 PS Medical have?
Medtronic PS Medical has 14 FDA 510(k) clearances (first 1996, latest 2002), across 8 product codes in 3 review panels.
How long does FDA take to clear Medtronic PS Medical's 510(k)s?
The median time from FDA receipt to decision across Medtronic PS Medical's cleared 510(k)s is 89 days.
What devices does Medtronic PS Medical make?
Its most frequent FDA product codes are GWG (Endoscope, Neurological, 4); JXG (Shunt, Central Nervous System And Components, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Has Medtronic PS Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Medtronic PS Medical. Related entities may recall under other names.
Next steps
- See all 14 Medtronic PS Medical clearances with predicates and recalls
- Run predicate analysis for product code GWG, Medtronic PS Medical'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.