MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,— 510(k) K010341

Substantially Equivalent

Medtronic PS Medical

FDA 510(k) clearance K010341 for MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,, Substantially Equivalent on 2001-04-20. Applicant: Medtronic PS Medical. Device class: 2.

Clearance details

Applicant
Medtronic PS Medical
Product code
Code GWG
Device class
Class 2
Regulation
21 CFR 882.1480
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Goleta, CA, US
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Adverse events under product code GWG

product code GWG
Death
5
Total
5

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.