RICHARDS INTRA-ARTICULAR SHAVER MOTOR— 510(k) K842475

Substantially Equivalent

Richards Medical Co., Inc.

FDA 510(k) clearance K842475 for RICHARDS INTRA-ARTICULAR SHAVER MOTOR, Substantially Equivalent on 1984-09-17. Applicant: Richards Medical Co., Inc..

Clearance details

Applicant
Richards Medical Co., Inc.
Product code
Code GEY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GEY

product code GEY
Malfunction
7,488
Total
7,488

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.