BIPOLAR PENCIL, MODEL 3901-002, 3900-002— 510(k) K010487
Substantially EquivalentMedtronic PS Medical
FDA 510(k) clearance K010487 for BIPOLAR PENCIL, MODEL 3901-002, 3900-002, Substantially Equivalent on 2001-05-03. Applicant: Medtronic PS Medical. Device class: 2.
Clearance details
- Applicant
- Medtronic PS Medical
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Goleta, CA, US
Recent devices under product code GEI
view allMore clearances from Medtronic PS Medical
view all- K012052 — MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
- K010361 — MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
- 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 GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.