FEMORAL CANAL BRUSH— 510(k) K810267

Substantially Equivalent

Richard'S Medical Equip., Inc.

FDA 510(k) clearance K810267 for FEMORAL CANAL BRUSH, Substantially Equivalent on 1981-02-09. Applicant: Richard'S Medical Equip., Inc..

Clearance details

Applicant
Richard'S Medical Equip., Inc.
Product code
Code LXH
Advisory panel
Orthopedic
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 LXH

product code LXH
Death
11
Injury
2,218
Malfunction
31,318
Total
33,547

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.