MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855— 510(k) K012052
Substantially EquivalentMedtronic PS Medical
FDA 510(k) clearance K012052 for MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855, Substantially Equivalent on 2002-02-11. Applicant: Medtronic PS Medical. Device class: 2.
Clearance details
- Applicant
- Medtronic PS Medical
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code JXG
view allMore clearances from Medtronic PS Medical
view all- K010361 — MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
- K010487 — BIPOLAR PENCIL, MODEL 3901-002, 3900-002
- K010341 — MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
- K003914 — MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
- K002572 — MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
Adverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.